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Restrictive transfusion strategy safe in cardiac surgery
ANAHEIM, CALIF. – Waiting to transfuse heart surgery patients until their hemoglobin drops below 7.5 g/dL is just as safe as transfusing them when their hemoglobin drops below 9.5 g/dL, and it saves a lot of blood, according to the TRICS III randomized, noninferiority trial of nearly 5,000 patients undergoing cardiac surgery with cardiopulmonary bypass.
Cardiac surgeons have been moving to more restrictive transfusion policies following reports of worse postoperative survival when patients are transfused. However, there are concerns about safety and uncertainty over whether it’s the transfusions themselves that are problematic or whether transfused patients do worse because they are sicker to begin with. The Transfusion Requirements in Cardiac Surgery (TRICS) III trial removes some of the doubt: “A restrictive transfusion strategy is as effective and safe as a liberal strategy in patients undergoing cardiac surgery,” said lead investigator C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
Overall, 11.4% in the restrictive-threshold group and 12.5% in the liberal-threshold group met the study’s composite primary outcome of death from any cause, MI, stroke, and new-onset renal failure with dialysis (P less than .001 for noninferiority). There were no statistically significant between-group differences in the individual components of the composite outcome. Mortality was 3% in the restrictive group and 3.6% in the liberal group, a 15% reduction for the restrictive group.
About 52% of the patients in the restrictive arm, compared with 72.6% in the liberal arm, were transfused. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units. The overall cost difference was roughly $3 million, Dr. Mazer said at the American Heart Association scientific sessions.
There were no statistically significant differences in secondary outcomes. Restrictive patients were on mechanical ventilation for a median of 0.38 days and in the ICU for a median of 2.1 days; patients in the liberal arm were ventilated for a median of 0.36 days and in the ICU for a median of 1.9 days. The median hospital stay was 8 days in both groups.
Unexpectedly, patients 75 years and older did better with the restrictive transfusion strategy, with a 30% lower risk of the composite outcome. “Many people think the older you are, the higher your hemoglobin should be, and the more liberal you should be with transfusions. We didn’t find that. [It] challenges current beliefs and may be considered to be hypothesis generating; at a minimum, it highlights that a restrictive transfusion strategy appears to be safe in elderly patients,” Dr. Mazer said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded from the study. The trial was conducted in 19 countries, including China and India, but “the results were remarkably consistent independent of where the sites were,” he said.
Results of the TRICS III trial were published simultaneously with Dr. Mazer’s presentation (N Engl J Med. 2017 Nov 12. doi: 10.1056/NEJMoa1711818).
The trial was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer reported personal fees from Amgen, Boehringer Ingelheim, Octapharma, and Pharmascience, as well as grants and personal fees from Fresenius Kabi.
This is an extremely important study. There have been multiple other trials, and, unfortunately, results have been quite equivocal. It’s incumbent upon us to figure out the best transfusion strategy, especially in cardiac surgery, since it is associated with a large amount of blood utilization. Also, there’ve been projections for a significant lack of blood supply in the future.
While the overall results showed no significant difference in outcomes between the groups, there was a numerical benefit evident in the restrictive group for the composite outcome, as well as all components of the main primary outcome except MI. This is not entirely unexpected, but we are really looking at the short-term effects here. I’m hoping that the longer-term outcomes will be evaluated, because they are extremely important.
Frank Sellke, MD , is chief of cardiothoracic surgery at Brown University in Providence, R.I. He made his comments after the study was presented at the American Heart Association scientific sessions. He was not involved with the work.
This is an extremely important study. There have been multiple other trials, and, unfortunately, results have been quite equivocal. It’s incumbent upon us to figure out the best transfusion strategy, especially in cardiac surgery, since it is associated with a large amount of blood utilization. Also, there’ve been projections for a significant lack of blood supply in the future.
While the overall results showed no significant difference in outcomes between the groups, there was a numerical benefit evident in the restrictive group for the composite outcome, as well as all components of the main primary outcome except MI. This is not entirely unexpected, but we are really looking at the short-term effects here. I’m hoping that the longer-term outcomes will be evaluated, because they are extremely important.
Frank Sellke, MD , is chief of cardiothoracic surgery at Brown University in Providence, R.I. He made his comments after the study was presented at the American Heart Association scientific sessions. He was not involved with the work.
This is an extremely important study. There have been multiple other trials, and, unfortunately, results have been quite equivocal. It’s incumbent upon us to figure out the best transfusion strategy, especially in cardiac surgery, since it is associated with a large amount of blood utilization. Also, there’ve been projections for a significant lack of blood supply in the future.
While the overall results showed no significant difference in outcomes between the groups, there was a numerical benefit evident in the restrictive group for the composite outcome, as well as all components of the main primary outcome except MI. This is not entirely unexpected, but we are really looking at the short-term effects here. I’m hoping that the longer-term outcomes will be evaluated, because they are extremely important.
Frank Sellke, MD , is chief of cardiothoracic surgery at Brown University in Providence, R.I. He made his comments after the study was presented at the American Heart Association scientific sessions. He was not involved with the work.
ANAHEIM, CALIF. – Waiting to transfuse heart surgery patients until their hemoglobin drops below 7.5 g/dL is just as safe as transfusing them when their hemoglobin drops below 9.5 g/dL, and it saves a lot of blood, according to the TRICS III randomized, noninferiority trial of nearly 5,000 patients undergoing cardiac surgery with cardiopulmonary bypass.
Cardiac surgeons have been moving to more restrictive transfusion policies following reports of worse postoperative survival when patients are transfused. However, there are concerns about safety and uncertainty over whether it’s the transfusions themselves that are problematic or whether transfused patients do worse because they are sicker to begin with. The Transfusion Requirements in Cardiac Surgery (TRICS) III trial removes some of the doubt: “A restrictive transfusion strategy is as effective and safe as a liberal strategy in patients undergoing cardiac surgery,” said lead investigator C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
Overall, 11.4% in the restrictive-threshold group and 12.5% in the liberal-threshold group met the study’s composite primary outcome of death from any cause, MI, stroke, and new-onset renal failure with dialysis (P less than .001 for noninferiority). There were no statistically significant between-group differences in the individual components of the composite outcome. Mortality was 3% in the restrictive group and 3.6% in the liberal group, a 15% reduction for the restrictive group.
About 52% of the patients in the restrictive arm, compared with 72.6% in the liberal arm, were transfused. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units. The overall cost difference was roughly $3 million, Dr. Mazer said at the American Heart Association scientific sessions.
There were no statistically significant differences in secondary outcomes. Restrictive patients were on mechanical ventilation for a median of 0.38 days and in the ICU for a median of 2.1 days; patients in the liberal arm were ventilated for a median of 0.36 days and in the ICU for a median of 1.9 days. The median hospital stay was 8 days in both groups.
Unexpectedly, patients 75 years and older did better with the restrictive transfusion strategy, with a 30% lower risk of the composite outcome. “Many people think the older you are, the higher your hemoglobin should be, and the more liberal you should be with transfusions. We didn’t find that. [It] challenges current beliefs and may be considered to be hypothesis generating; at a minimum, it highlights that a restrictive transfusion strategy appears to be safe in elderly patients,” Dr. Mazer said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded from the study. The trial was conducted in 19 countries, including China and India, but “the results were remarkably consistent independent of where the sites were,” he said.
Results of the TRICS III trial were published simultaneously with Dr. Mazer’s presentation (N Engl J Med. 2017 Nov 12. doi: 10.1056/NEJMoa1711818).
The trial was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer reported personal fees from Amgen, Boehringer Ingelheim, Octapharma, and Pharmascience, as well as grants and personal fees from Fresenius Kabi.
ANAHEIM, CALIF. – Waiting to transfuse heart surgery patients until their hemoglobin drops below 7.5 g/dL is just as safe as transfusing them when their hemoglobin drops below 9.5 g/dL, and it saves a lot of blood, according to the TRICS III randomized, noninferiority trial of nearly 5,000 patients undergoing cardiac surgery with cardiopulmonary bypass.
Cardiac surgeons have been moving to more restrictive transfusion policies following reports of worse postoperative survival when patients are transfused. However, there are concerns about safety and uncertainty over whether it’s the transfusions themselves that are problematic or whether transfused patients do worse because they are sicker to begin with. The Transfusion Requirements in Cardiac Surgery (TRICS) III trial removes some of the doubt: “A restrictive transfusion strategy is as effective and safe as a liberal strategy in patients undergoing cardiac surgery,” said lead investigator C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
Overall, 11.4% in the restrictive-threshold group and 12.5% in the liberal-threshold group met the study’s composite primary outcome of death from any cause, MI, stroke, and new-onset renal failure with dialysis (P less than .001 for noninferiority). There were no statistically significant between-group differences in the individual components of the composite outcome. Mortality was 3% in the restrictive group and 3.6% in the liberal group, a 15% reduction for the restrictive group.
About 52% of the patients in the restrictive arm, compared with 72.6% in the liberal arm, were transfused. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units. The overall cost difference was roughly $3 million, Dr. Mazer said at the American Heart Association scientific sessions.
There were no statistically significant differences in secondary outcomes. Restrictive patients were on mechanical ventilation for a median of 0.38 days and in the ICU for a median of 2.1 days; patients in the liberal arm were ventilated for a median of 0.36 days and in the ICU for a median of 1.9 days. The median hospital stay was 8 days in both groups.
Unexpectedly, patients 75 years and older did better with the restrictive transfusion strategy, with a 30% lower risk of the composite outcome. “Many people think the older you are, the higher your hemoglobin should be, and the more liberal you should be with transfusions. We didn’t find that. [It] challenges current beliefs and may be considered to be hypothesis generating; at a minimum, it highlights that a restrictive transfusion strategy appears to be safe in elderly patients,” Dr. Mazer said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded from the study. The trial was conducted in 19 countries, including China and India, but “the results were remarkably consistent independent of where the sites were,” he said.
Results of the TRICS III trial were published simultaneously with Dr. Mazer’s presentation (N Engl J Med. 2017 Nov 12. doi: 10.1056/NEJMoa1711818).
The trial was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer reported personal fees from Amgen, Boehringer Ingelheim, Octapharma, and Pharmascience, as well as grants and personal fees from Fresenius Kabi.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Overall, 11.4% in the restrictive-threshold group, versus 12.5% in the liberal-threshold group, met the study’s composite primary outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis.
Data source: TRICS III, a randomized, noninferiority trial with almost 5,000 participants
Disclosures: TRICS III was funded by the Canadian Institutes of Health Research, among others. The lead investigator reported personal fees from Amgen, Boehringer Ingelheim, Octapharma, and Pharmascience, as well as grants and personal fees from Fresenius Kabi.
Lung injury risk higher with apheresis blood products
SAN DIEGO – , according to research presented at the annual meeting of the American Association of Blood Banks.
Compared with other RBC products, those derived from apheresis significantly increased pulmonary cell interleukin (IL)–6 and IL-8 production, and this was further exacerbated by cell stretching. Conversely, red cell–filtered products appeared to be the least likely to cause cell injury.
“Several studies have shown that red blood cell transfusion is associated with acute lung injury, and transfusion induces leakage in ICU patients,” said lead study author Mathijs Wirtz, MD, of the Academic Medical Center, Amsterdam.
ICU patients who did not receive any transfusions had significantly lower leakage than those who were transfused. “There also seems to be a synergy between transfusion and mechanical ventilation,” Dr. Wirtz said.
Studies have also shown that there are differences in the prevalence of transfusion-related acute lung injury, when comparing Europe to the United States. Storage and manufacturing methods do differ between Europe and the United States, Dr. Wirtz noted. “This led to our hypothesis that lung injury inflicted by red blood cell transfusion is influenced by manufacturing methods.”
In this study, Dr. Wirtz and his colleagues investigated the response of pulmonary cells to the different methods of manufacturing RBC products. Using type A or B blood obtained from eight donors, a variety of RBC products were manufactured for the study, including whole-blood filtered, red-cell filtered, apheresis derived, and whole-blood derived.
For measuring thrombin generation and analyzing extracellular vesicles (EV), supernatants were prepared after 4-5 days of storage for fresh and 41-42 days for stored. The researchers selected A549 type II alveolar cells to seed onto flexible membranes, which were then incubated with RBC supernatant also stretched 25% using a cell stretcher.
After 24 hours, the production of IL-8 and IL-6 was measured.
Both fresh and stored supernatants that were derived from apheresis significantly increased the production of IL-6 and IL-8 in pulmonary cells, compared with nonincubated controls and most of the other RBC products. The production of IL-6 and IL-8 was exacerbated by cell stretching.
Average IL-6 production in nonstretched cells was 91 pg/mL for fresh and 87 pg/mL for expired (P less than .05 vs. control and other RBC products). For stretched cells, it was 130 pg/mL and 150 pg/mL (P less than .05 vs. control). For controls, mean nonstretched and stretched production was 21 pg/mL and 85 pg/mL.
Mean IL-8 production in nonstretched cells was 2,100 pg/mL for fresh and 1,900 pg/mL for stored (P less than .05 vs. control and other RBC products). For stretched cells, the means were 4,100 pg/mL for fresh and 5,200 pg/mL for stored (P less than .05 vs. control).
The average nonstretched and stretched control IL-8 production was 1,200 pg/mL for fresh and 4,300 pg/mL for stored.
Products derived from apheresis also demonstrated a significantly higher ability to generate thrombin, compared with other RBC products, and a significantly increased number of RBC-derived EVs, compared with filtered red cell and whole blood–derived products (P less than .05).
However, incubated stretched cells from stored whole blood–filtered products had higher IL-8 production (16,000 pg/mL), compared with other products and stretched controls. The lowest mean levels of IL-6 were observed in supernatants derived from red cell–filtered products (nonstretched fresh and expired, 12 pg/mL and 8 pg/mL; stretched, 40 pg/mL and 36 pg/mL) and they did not appear to activate pulmonary cells. Levels of EVs were also low, compared with other blood products.
“We can conclude that manufacturing methods contribute to the differences in inducing lung injury, and especially the apheresis-derived products, which induced the most consistent injury in our model,” Dr. Wirtz said. “The red cell–filtered products appeared to be the safest.”
Dr. Wirtz had no disclosures.
SAN DIEGO – , according to research presented at the annual meeting of the American Association of Blood Banks.
Compared with other RBC products, those derived from apheresis significantly increased pulmonary cell interleukin (IL)–6 and IL-8 production, and this was further exacerbated by cell stretching. Conversely, red cell–filtered products appeared to be the least likely to cause cell injury.
“Several studies have shown that red blood cell transfusion is associated with acute lung injury, and transfusion induces leakage in ICU patients,” said lead study author Mathijs Wirtz, MD, of the Academic Medical Center, Amsterdam.
ICU patients who did not receive any transfusions had significantly lower leakage than those who were transfused. “There also seems to be a synergy between transfusion and mechanical ventilation,” Dr. Wirtz said.
Studies have also shown that there are differences in the prevalence of transfusion-related acute lung injury, when comparing Europe to the United States. Storage and manufacturing methods do differ between Europe and the United States, Dr. Wirtz noted. “This led to our hypothesis that lung injury inflicted by red blood cell transfusion is influenced by manufacturing methods.”
In this study, Dr. Wirtz and his colleagues investigated the response of pulmonary cells to the different methods of manufacturing RBC products. Using type A or B blood obtained from eight donors, a variety of RBC products were manufactured for the study, including whole-blood filtered, red-cell filtered, apheresis derived, and whole-blood derived.
For measuring thrombin generation and analyzing extracellular vesicles (EV), supernatants were prepared after 4-5 days of storage for fresh and 41-42 days for stored. The researchers selected A549 type II alveolar cells to seed onto flexible membranes, which were then incubated with RBC supernatant also stretched 25% using a cell stretcher.
After 24 hours, the production of IL-8 and IL-6 was measured.
Both fresh and stored supernatants that were derived from apheresis significantly increased the production of IL-6 and IL-8 in pulmonary cells, compared with nonincubated controls and most of the other RBC products. The production of IL-6 and IL-8 was exacerbated by cell stretching.
Average IL-6 production in nonstretched cells was 91 pg/mL for fresh and 87 pg/mL for expired (P less than .05 vs. control and other RBC products). For stretched cells, it was 130 pg/mL and 150 pg/mL (P less than .05 vs. control). For controls, mean nonstretched and stretched production was 21 pg/mL and 85 pg/mL.
Mean IL-8 production in nonstretched cells was 2,100 pg/mL for fresh and 1,900 pg/mL for stored (P less than .05 vs. control and other RBC products). For stretched cells, the means were 4,100 pg/mL for fresh and 5,200 pg/mL for stored (P less than .05 vs. control).
The average nonstretched and stretched control IL-8 production was 1,200 pg/mL for fresh and 4,300 pg/mL for stored.
Products derived from apheresis also demonstrated a significantly higher ability to generate thrombin, compared with other RBC products, and a significantly increased number of RBC-derived EVs, compared with filtered red cell and whole blood–derived products (P less than .05).
However, incubated stretched cells from stored whole blood–filtered products had higher IL-8 production (16,000 pg/mL), compared with other products and stretched controls. The lowest mean levels of IL-6 were observed in supernatants derived from red cell–filtered products (nonstretched fresh and expired, 12 pg/mL and 8 pg/mL; stretched, 40 pg/mL and 36 pg/mL) and they did not appear to activate pulmonary cells. Levels of EVs were also low, compared with other blood products.
“We can conclude that manufacturing methods contribute to the differences in inducing lung injury, and especially the apheresis-derived products, which induced the most consistent injury in our model,” Dr. Wirtz said. “The red cell–filtered products appeared to be the safest.”
Dr. Wirtz had no disclosures.
SAN DIEGO – , according to research presented at the annual meeting of the American Association of Blood Banks.
Compared with other RBC products, those derived from apheresis significantly increased pulmonary cell interleukin (IL)–6 and IL-8 production, and this was further exacerbated by cell stretching. Conversely, red cell–filtered products appeared to be the least likely to cause cell injury.
“Several studies have shown that red blood cell transfusion is associated with acute lung injury, and transfusion induces leakage in ICU patients,” said lead study author Mathijs Wirtz, MD, of the Academic Medical Center, Amsterdam.
ICU patients who did not receive any transfusions had significantly lower leakage than those who were transfused. “There also seems to be a synergy between transfusion and mechanical ventilation,” Dr. Wirtz said.
Studies have also shown that there are differences in the prevalence of transfusion-related acute lung injury, when comparing Europe to the United States. Storage and manufacturing methods do differ between Europe and the United States, Dr. Wirtz noted. “This led to our hypothesis that lung injury inflicted by red blood cell transfusion is influenced by manufacturing methods.”
In this study, Dr. Wirtz and his colleagues investigated the response of pulmonary cells to the different methods of manufacturing RBC products. Using type A or B blood obtained from eight donors, a variety of RBC products were manufactured for the study, including whole-blood filtered, red-cell filtered, apheresis derived, and whole-blood derived.
For measuring thrombin generation and analyzing extracellular vesicles (EV), supernatants were prepared after 4-5 days of storage for fresh and 41-42 days for stored. The researchers selected A549 type II alveolar cells to seed onto flexible membranes, which were then incubated with RBC supernatant also stretched 25% using a cell stretcher.
After 24 hours, the production of IL-8 and IL-6 was measured.
Both fresh and stored supernatants that were derived from apheresis significantly increased the production of IL-6 and IL-8 in pulmonary cells, compared with nonincubated controls and most of the other RBC products. The production of IL-6 and IL-8 was exacerbated by cell stretching.
Average IL-6 production in nonstretched cells was 91 pg/mL for fresh and 87 pg/mL for expired (P less than .05 vs. control and other RBC products). For stretched cells, it was 130 pg/mL and 150 pg/mL (P less than .05 vs. control). For controls, mean nonstretched and stretched production was 21 pg/mL and 85 pg/mL.
Mean IL-8 production in nonstretched cells was 2,100 pg/mL for fresh and 1,900 pg/mL for stored (P less than .05 vs. control and other RBC products). For stretched cells, the means were 4,100 pg/mL for fresh and 5,200 pg/mL for stored (P less than .05 vs. control).
The average nonstretched and stretched control IL-8 production was 1,200 pg/mL for fresh and 4,300 pg/mL for stored.
Products derived from apheresis also demonstrated a significantly higher ability to generate thrombin, compared with other RBC products, and a significantly increased number of RBC-derived EVs, compared with filtered red cell and whole blood–derived products (P less than .05).
However, incubated stretched cells from stored whole blood–filtered products had higher IL-8 production (16,000 pg/mL), compared with other products and stretched controls. The lowest mean levels of IL-6 were observed in supernatants derived from red cell–filtered products (nonstretched fresh and expired, 12 pg/mL and 8 pg/mL; stretched, 40 pg/mL and 36 pg/mL) and they did not appear to activate pulmonary cells. Levels of EVs were also low, compared with other blood products.
“We can conclude that manufacturing methods contribute to the differences in inducing lung injury, and especially the apheresis-derived products, which induced the most consistent injury in our model,” Dr. Wirtz said. “The red cell–filtered products appeared to be the safest.”
Dr. Wirtz had no disclosures.
From AABB17
Key clinical point: The method of manufacturing blood products can markedly influence the interaction of RBC products with lung cells, especially in patients on mechanical ventilation.
Major finding: Apheresis-derived products are the most consistent in causing injuries, while red cell–filtered products appear to be the safest in avoiding lung injury.
Data source: An experimental study that investigated different manufacturing methods of RBC products and the response of pulmonary cells in an in vitro model of mechanical ventilation.
Disclosures: Dr. Wirtz had no disclosures.
Red cell age: No impact on mortality after transfusion
Critically ill patients who received transfusions of the freshest-available red cells had a mortality rate similar to that of patients who received standard-issue, oldest-available red cells, according to results from a large randomized trial.
In some earlier studies, transfusion of older red cells was linked to increased mortality for critically ill, surgical, and trauma patients. But the new results provide “strong evidence” that transfusing very fresh red cells rather than older red cells “provides no clinically meaningful benefits” in the critically ill population, reported D. James Cooper, MD, of Monash University, Melbourne, and his colleagues.
“Our results support the current international usual practice of transfusing patients with the oldest red cells available,” the researchers wrote in the report on the trial, known as TRANSFUSE (Standard Issue Transfusion versus Fresher Red-Cell Use in Intensive Care).
Red cells are stored up to 42 days and can undergo biochemical, structural, or metabolic changes during that time that “may cause harm,” the researchers wrote. However, blood banks typically issue the oldest compatible red cell units available to them, and it’s uncertain whether doing so increases mortality.
To see if the age of red cells impacted mortality, Dr. Cooper and has colleagues at 59 centers in five countries randomized 4,994 critically ill adults to receive the freshest-available or standard oldest-available red cells (N Engl J Med. 2017;377:1858-67).
At 90 days after transfusion, mortality was 24.8% in the group of patients receiving the freshest-available red cells, and 24.1% for the oldest-available group, or an absolute risk difference of just 0.7 percentage points (95% confidence interval, –1.7 to 3.1; P = .57).
“Among the many secondary outcomes tested, we noted a nominal difference in febrile nonhemolytic transfusion reactions that was small, and we are not sure of its clinical significance,” the researchers wrote.
The average duration of red cell storage was 11.8 days versus 22.4 days for the freshest-available and oldest-available groups, respectively.
The TRANSFUSE trial is not the first to suggest that age of red blood cells does not make a difference in mortality after transfusion. There were two earlier trials, ABLE (Age of Blood Evaluation) and INFORM (Informing Fresh versus Old Red Cell Management) that came to similar conclusions. However, the ABLE trial had a small sample size, and INFORM had “limited outcome data” including a low mortality rate “suggesting low illness severity,” the researchers noted.
“The lower in-hospital mortality in the ICU subgroup in the INFORM trial (13.0%) than that observed in our trial at 90 days (24.5%) is consistent with lower illness severity in the INFORM patients,” they wrote.
The study was funded by organizations including the Australian National Health and Medical Research Council. Dr. Cooper reported receiving consulting fees from Eustralis Pharmaceuticals that were paid to Monash University. No other potential conflicts of interest were reported.
Critically ill patients who received transfusions of the freshest-available red cells had a mortality rate similar to that of patients who received standard-issue, oldest-available red cells, according to results from a large randomized trial.
In some earlier studies, transfusion of older red cells was linked to increased mortality for critically ill, surgical, and trauma patients. But the new results provide “strong evidence” that transfusing very fresh red cells rather than older red cells “provides no clinically meaningful benefits” in the critically ill population, reported D. James Cooper, MD, of Monash University, Melbourne, and his colleagues.
“Our results support the current international usual practice of transfusing patients with the oldest red cells available,” the researchers wrote in the report on the trial, known as TRANSFUSE (Standard Issue Transfusion versus Fresher Red-Cell Use in Intensive Care).
Red cells are stored up to 42 days and can undergo biochemical, structural, or metabolic changes during that time that “may cause harm,” the researchers wrote. However, blood banks typically issue the oldest compatible red cell units available to them, and it’s uncertain whether doing so increases mortality.
To see if the age of red cells impacted mortality, Dr. Cooper and has colleagues at 59 centers in five countries randomized 4,994 critically ill adults to receive the freshest-available or standard oldest-available red cells (N Engl J Med. 2017;377:1858-67).
At 90 days after transfusion, mortality was 24.8% in the group of patients receiving the freshest-available red cells, and 24.1% for the oldest-available group, or an absolute risk difference of just 0.7 percentage points (95% confidence interval, –1.7 to 3.1; P = .57).
“Among the many secondary outcomes tested, we noted a nominal difference in febrile nonhemolytic transfusion reactions that was small, and we are not sure of its clinical significance,” the researchers wrote.
The average duration of red cell storage was 11.8 days versus 22.4 days for the freshest-available and oldest-available groups, respectively.
The TRANSFUSE trial is not the first to suggest that age of red blood cells does not make a difference in mortality after transfusion. There were two earlier trials, ABLE (Age of Blood Evaluation) and INFORM (Informing Fresh versus Old Red Cell Management) that came to similar conclusions. However, the ABLE trial had a small sample size, and INFORM had “limited outcome data” including a low mortality rate “suggesting low illness severity,” the researchers noted.
“The lower in-hospital mortality in the ICU subgroup in the INFORM trial (13.0%) than that observed in our trial at 90 days (24.5%) is consistent with lower illness severity in the INFORM patients,” they wrote.
The study was funded by organizations including the Australian National Health and Medical Research Council. Dr. Cooper reported receiving consulting fees from Eustralis Pharmaceuticals that were paid to Monash University. No other potential conflicts of interest were reported.
Critically ill patients who received transfusions of the freshest-available red cells had a mortality rate similar to that of patients who received standard-issue, oldest-available red cells, according to results from a large randomized trial.
In some earlier studies, transfusion of older red cells was linked to increased mortality for critically ill, surgical, and trauma patients. But the new results provide “strong evidence” that transfusing very fresh red cells rather than older red cells “provides no clinically meaningful benefits” in the critically ill population, reported D. James Cooper, MD, of Monash University, Melbourne, and his colleagues.
“Our results support the current international usual practice of transfusing patients with the oldest red cells available,” the researchers wrote in the report on the trial, known as TRANSFUSE (Standard Issue Transfusion versus Fresher Red-Cell Use in Intensive Care).
Red cells are stored up to 42 days and can undergo biochemical, structural, or metabolic changes during that time that “may cause harm,” the researchers wrote. However, blood banks typically issue the oldest compatible red cell units available to them, and it’s uncertain whether doing so increases mortality.
To see if the age of red cells impacted mortality, Dr. Cooper and has colleagues at 59 centers in five countries randomized 4,994 critically ill adults to receive the freshest-available or standard oldest-available red cells (N Engl J Med. 2017;377:1858-67).
At 90 days after transfusion, mortality was 24.8% in the group of patients receiving the freshest-available red cells, and 24.1% for the oldest-available group, or an absolute risk difference of just 0.7 percentage points (95% confidence interval, –1.7 to 3.1; P = .57).
“Among the many secondary outcomes tested, we noted a nominal difference in febrile nonhemolytic transfusion reactions that was small, and we are not sure of its clinical significance,” the researchers wrote.
The average duration of red cell storage was 11.8 days versus 22.4 days for the freshest-available and oldest-available groups, respectively.
The TRANSFUSE trial is not the first to suggest that age of red blood cells does not make a difference in mortality after transfusion. There were two earlier trials, ABLE (Age of Blood Evaluation) and INFORM (Informing Fresh versus Old Red Cell Management) that came to similar conclusions. However, the ABLE trial had a small sample size, and INFORM had “limited outcome data” including a low mortality rate “suggesting low illness severity,” the researchers noted.
“The lower in-hospital mortality in the ICU subgroup in the INFORM trial (13.0%) than that observed in our trial at 90 days (24.5%) is consistent with lower illness severity in the INFORM patients,” they wrote.
The study was funded by organizations including the Australian National Health and Medical Research Council. Dr. Cooper reported receiving consulting fees from Eustralis Pharmaceuticals that were paid to Monash University. No other potential conflicts of interest were reported.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point:
Major finding: Mortality at 90 days after transfusion was 24.8% in patients receiving the freshest-available red cells and 24.1% in patients receiving standard-issue, oldest-available red cells (P = 0.57).
Data source: An international, randomized, double-blind trial including nearly 5,000 critically ill adults at 59 centers in five countries.
Disclosures: The study was funded by organizations including the Australian National Health and Medical Research Council. Dr. Cooper reported receiving consulting fees from Eustralis Pharmaceuticals that were paid to Monash University. No other potential conflicts of interest were reported.
Cold stored platelets control bleeding after complex cardiac surgery
SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.
The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.
“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”
There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.
In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.
The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.
Platelet counts and hemoglobin levels also did not significantly differ between groups.
As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.
Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.
“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.
SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.
The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.
“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”
There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.
In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.
The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.
Platelet counts and hemoglobin levels also did not significantly differ between groups.
As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.
Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.
“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.
SAN DIEGO – Cold stored leukoreduced apheresis platelets in platelet additive solution were effective for controlling bleeding in a small study of patients undergoing complex cardiothoracic surgery, according to findings presented at the annual meeting of the American Association of Blood Banks.
The volume of postoperative bleeding was significantly lower among patients who received cold stored platelets compared with those who received standard room temperature storage platelets. Thromboembolic events did not differ between the two groups, nor did measures of coagulation at varying time points. Platelet counts and blood usage were also similar in the two groups. The study was small, however, and further studies are needed to confirm the findings.
“These patients are undergoing major surgery and are at high risk in every aspect,” said Torunn Oveland Apelseth, MD, PhD, of the Laboratory of Clinical Biochemistry, Haukeland (Norway) University Hospital. “They are at high risk for bleeding, at high risk for thromboembolic events and high blood usage, and there is a need for optimized blood components.”
There has been debate over the use of cold stored platelets, she noted. While storage at 4° C shortens platelet circulation time, some research shows that cold stored platelets have better hemostatic function.
In this study, one patient cohort was transfused with leukoreduced apheresis platelets stored at 4° C in platelet additive solution for up to 7 days under constant agitation, while the other group received platelets stored at standard room temperature. The study endpoints were comparisons between the two groups of postoperative bleeding, total blood usage, and laboratory measures of coagulation and blood cell counts within the first postoperative day. Thromboembolic events in the 28 days after surgery were also evaluated.
The study evaluated 17 patients who received cold stored platelets and 22 who received room temperature storage platelets. Patient demographics for the two groups were similar – as were their international normalized ratios, activated partial thromboplastin times, and fibrinogen levels – before surgery, immediately after heparin reversal, and the morning following the procedure.
Platelet counts and hemoglobin levels also did not significantly differ between groups.
As measured by chest drain output after chest closure, patients who received cold stored platelets had a significantly lower median amount of bleeding in the postoperative period compared with patients given room temperature storage platelets: 576 mL vs. 838 mL. Average chest drain output after chest closure was 594 mL in those who did not receive any transfusions.
Thromboembolic events occurred in 3 patients (18%) who received cold stored platelets and 7 (31%) of those given room temperature storage platelets. The difference was not statistically significant. In addition, blood usage – platelets, red blood cells, and solvent/detergent-treated pooled plasma – was similar for the two cohorts.
“There were also no differences in the number of thromboembolic episodes or length of stay in ICU,” said Dr. Apelseth, who recommended larger studies to explore the use of use of cold stored platelet transfusion in the critical care setting.
AT AABB17
Key clinical point: Cold stored leukoreduced apheresis platelets in platelet additive solution are effective for treating bleeding in patients undergoing complex cardiothoracic surgery.
Major finding: Patients who underwent procedures requiring cardiopulmonary bypass circulation had a significantly lower median amount of bleeding in the postoperative period with cold stored platelets compared with standard room temperature platelets: 576 mL vs. 838 mL.
Data source: Randomized two-arm pilot trial of cardiothoracic surgery patients.
Disclosures: The authors have no relevant financial disclosures.
Citrate reactions seen in 7% of apheresis donations
SAN DIEGO – , based on data presented from Héma-Québec, Montreal, presented at the annual meeting of the American Association of Blood Banks.
Vasovagal reactions were seen in 2.5% of procedures, and reactions with loss of consciousness occurred in 0.1%, reported Pierre Robillard, MD, of McGill University and Héma-Québec.
The fairly high rates of adverse reactions speak to the importance of taking preventive measures in donors undergoing apheresis, he said. Hypocalcemia and other citrate-induced abnormalities can affect neuromuscular and cardiac function. Most reactions are mild dysesthesias, but tetany, seizures, and cardiac arrhythmias can occur. Prophylactic oral or intravenous calcium supplements can correct decreased ionized calcium levels and manage the symptoms of hypocalcemia, which are especially likely in procedures involving platelet collection.
Donor exposure to citrate can vary depending on the type and length of the specific apheresis procedure as well as the type of system used, he said. The risk for vasovagal reactions also varies with the type of procedure performed and the use of volume replacement.
Dr. Robillard and his colleagues examined the severity of all cases of donor complications reported to Héma-Québec, beginning in October 2015. A Trima Accel system by Terumo BCT was used for single and double red blood cell collection, single and double platelets, platelets plus plasma, platelets plus red blood cells, platelets plus red blood cells plus plasma, double platelets plus red blood cells, and double platelets plus plasma. Plasma for fractionation was collected with a PCS®2 Plasma Collection System by Haemonetics.
During the study period, 80,409 apheresis procedures were conducted, involving 14,742 donors. Within this cohort, 5,447 (6.8%) had citrate reactions; 2,006 (2.5%) had vasovagal reactions without loss of consciousness, and 77 (0.1%) had vasovagal reactions with loss of consciousness.
Three quarters of the donors (74%) were male, and rates of citrate reactions were higher in men than in women (7% vs. 6%, P less than .001). There was a linear association between level of citrate exposure and citrate reactions rates (P less than .001).
“Vasovagal reactions were four times higher for female donors than for males, with or without loss of consciousness, and this difference was statistically significant,” said Dr. Robillard. Vasovagal reactions were higher in first-time donors.
The rate of vasovagal reactions without loss of consciousness was 6.2% in women and 1.6% in men, (P less than .001). Vasovagal reactions with loss of consciousness affected 0.22% of women and 0.06% of men (P less than .001).
The rates of citrate reactions were similar at all ages, but the rates of vasovagal reactions declined with age; the rates were 6.1% in patients aged 18-22 years and 1% among those over age 70.
SAN DIEGO – , based on data presented from Héma-Québec, Montreal, presented at the annual meeting of the American Association of Blood Banks.
Vasovagal reactions were seen in 2.5% of procedures, and reactions with loss of consciousness occurred in 0.1%, reported Pierre Robillard, MD, of McGill University and Héma-Québec.
The fairly high rates of adverse reactions speak to the importance of taking preventive measures in donors undergoing apheresis, he said. Hypocalcemia and other citrate-induced abnormalities can affect neuromuscular and cardiac function. Most reactions are mild dysesthesias, but tetany, seizures, and cardiac arrhythmias can occur. Prophylactic oral or intravenous calcium supplements can correct decreased ionized calcium levels and manage the symptoms of hypocalcemia, which are especially likely in procedures involving platelet collection.
Donor exposure to citrate can vary depending on the type and length of the specific apheresis procedure as well as the type of system used, he said. The risk for vasovagal reactions also varies with the type of procedure performed and the use of volume replacement.
Dr. Robillard and his colleagues examined the severity of all cases of donor complications reported to Héma-Québec, beginning in October 2015. A Trima Accel system by Terumo BCT was used for single and double red blood cell collection, single and double platelets, platelets plus plasma, platelets plus red blood cells, platelets plus red blood cells plus plasma, double platelets plus red blood cells, and double platelets plus plasma. Plasma for fractionation was collected with a PCS®2 Plasma Collection System by Haemonetics.
During the study period, 80,409 apheresis procedures were conducted, involving 14,742 donors. Within this cohort, 5,447 (6.8%) had citrate reactions; 2,006 (2.5%) had vasovagal reactions without loss of consciousness, and 77 (0.1%) had vasovagal reactions with loss of consciousness.
Three quarters of the donors (74%) were male, and rates of citrate reactions were higher in men than in women (7% vs. 6%, P less than .001). There was a linear association between level of citrate exposure and citrate reactions rates (P less than .001).
“Vasovagal reactions were four times higher for female donors than for males, with or without loss of consciousness, and this difference was statistically significant,” said Dr. Robillard. Vasovagal reactions were higher in first-time donors.
The rate of vasovagal reactions without loss of consciousness was 6.2% in women and 1.6% in men, (P less than .001). Vasovagal reactions with loss of consciousness affected 0.22% of women and 0.06% of men (P less than .001).
The rates of citrate reactions were similar at all ages, but the rates of vasovagal reactions declined with age; the rates were 6.1% in patients aged 18-22 years and 1% among those over age 70.
SAN DIEGO – , based on data presented from Héma-Québec, Montreal, presented at the annual meeting of the American Association of Blood Banks.
Vasovagal reactions were seen in 2.5% of procedures, and reactions with loss of consciousness occurred in 0.1%, reported Pierre Robillard, MD, of McGill University and Héma-Québec.
The fairly high rates of adverse reactions speak to the importance of taking preventive measures in donors undergoing apheresis, he said. Hypocalcemia and other citrate-induced abnormalities can affect neuromuscular and cardiac function. Most reactions are mild dysesthesias, but tetany, seizures, and cardiac arrhythmias can occur. Prophylactic oral or intravenous calcium supplements can correct decreased ionized calcium levels and manage the symptoms of hypocalcemia, which are especially likely in procedures involving platelet collection.
Donor exposure to citrate can vary depending on the type and length of the specific apheresis procedure as well as the type of system used, he said. The risk for vasovagal reactions also varies with the type of procedure performed and the use of volume replacement.
Dr. Robillard and his colleagues examined the severity of all cases of donor complications reported to Héma-Québec, beginning in October 2015. A Trima Accel system by Terumo BCT was used for single and double red blood cell collection, single and double platelets, platelets plus plasma, platelets plus red blood cells, platelets plus red blood cells plus plasma, double platelets plus red blood cells, and double platelets plus plasma. Plasma for fractionation was collected with a PCS®2 Plasma Collection System by Haemonetics.
During the study period, 80,409 apheresis procedures were conducted, involving 14,742 donors. Within this cohort, 5,447 (6.8%) had citrate reactions; 2,006 (2.5%) had vasovagal reactions without loss of consciousness, and 77 (0.1%) had vasovagal reactions with loss of consciousness.
Three quarters of the donors (74%) were male, and rates of citrate reactions were higher in men than in women (7% vs. 6%, P less than .001). There was a linear association between level of citrate exposure and citrate reactions rates (P less than .001).
“Vasovagal reactions were four times higher for female donors than for males, with or without loss of consciousness, and this difference was statistically significant,” said Dr. Robillard. Vasovagal reactions were higher in first-time donors.
The rate of vasovagal reactions without loss of consciousness was 6.2% in women and 1.6% in men, (P less than .001). Vasovagal reactions with loss of consciousness affected 0.22% of women and 0.06% of men (P less than .001).
The rates of citrate reactions were similar at all ages, but the rates of vasovagal reactions declined with age; the rates were 6.1% in patients aged 18-22 years and 1% among those over age 70.
AT AABB17
Key clinical point: Adverse reactions to apheresis donations can be significant; calcium supplements can reduce the risk of citrate reactions and volume replacement can reduce the risk of vasovagal reactions in donors.
Major finding: Citrate reactions accompanied 6.8% of donations; 2.5% had vasovagal reactions without loss of consciousness and 0.1% had loss of consciousness.
Data source: A study at Héma-Québec, Montreal, of 80,409 apheresis procedures conducted in 14,742 donors.
Disclosures: Dr. Robillard had no disclosures.
State regulations for tattoo facilities increased blood donor pools
SAN DIEGO – Tattoos are rapidly moving into mainstream America, and as more states regulate tattoo facilities, persons with tattoos can be blood donors without compromising patient safety, Mary Townsend of Blood Systems Inc. reported at the annual meeting of the American Association of Blood Banks.
“Two big states – Arizona and California – were added to the list of approved states, and we had a gain of 2,216 donors in California during a 3-month period and a gain of 4,035 donors in Arizona over 4 months,” Ms. Townsend said.
Both the AABB and the Food and Drug Administration require a 12-month deferral of donors after they have received tattoos using nonsterile needles or reusable ink. The FDA’s current 2015 guidance also states that tattooed donors can give plasma as soon as the inked area has healed if they reside in a state with applied inspections and licenses for tattoo facilities, and if a sterile needle and ink were used.
Blood Systems monitors state regulations to see if they require tattoo establishments to be licensed and require the use of sterile needles and non-reusable ink. To be considered an approved state, the regulations have to be statewide, covering all jurisdictions.
In the study, Ms. Townsend and her colleagues compared the rates of donors who were deferred before and after Arizona and California were added to the list of approved states, to determine the potential gain in donors with changes in state tattoo licensing regulations.
They analyzed blood centers in California and Arizona before and after implementation of state tattoo regulations, and also screened individuals who had received tattoos in those states with the question: “In the past 12 months have you had a tattoo?” and if the answer was ‘yes,’ if the tattoo was applied by a state regulated facility.
For California, they compared two periods – 3 months before regulations were implemented (February to April of 2015) and 3 months after (February to April of 2016) regulations were implemented. For Arizona, they selected a 4-month period (December 2015 to March 2016) and 4 months afterward (December 2016 to March 2017).
A higher proportion of donors who came to centers to donate blood admitted to having gotten a tattoo within the last 12 months in the postregulatory period in both states. The increase in donors occurred immediately following the addition of both states to the Acceptable States List. Accepted donors increased 13-fold in California and 3-fold in Arizona. The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.
For blood donors who received a tattoo in a regulated state, blood donations were reviewed for the presence of infectious disease markers including HIV, hepatitis B, and hepatitis C. All donors who had received a tattoo in a regulated state tested negative for HIV, HBV, and HCV.
“Roughly one in three people (in the United States) have a tattoo and, of those, about 70% have more than one tattoo. The bottom line is that 45 million Americans have at least one tattoo,” she said. As state regulations adhere to guidelines regarding tattoos and blood donation, the pool of donors increases.
SAN DIEGO – Tattoos are rapidly moving into mainstream America, and as more states regulate tattoo facilities, persons with tattoos can be blood donors without compromising patient safety, Mary Townsend of Blood Systems Inc. reported at the annual meeting of the American Association of Blood Banks.
“Two big states – Arizona and California – were added to the list of approved states, and we had a gain of 2,216 donors in California during a 3-month period and a gain of 4,035 donors in Arizona over 4 months,” Ms. Townsend said.
Both the AABB and the Food and Drug Administration require a 12-month deferral of donors after they have received tattoos using nonsterile needles or reusable ink. The FDA’s current 2015 guidance also states that tattooed donors can give plasma as soon as the inked area has healed if they reside in a state with applied inspections and licenses for tattoo facilities, and if a sterile needle and ink were used.
Blood Systems monitors state regulations to see if they require tattoo establishments to be licensed and require the use of sterile needles and non-reusable ink. To be considered an approved state, the regulations have to be statewide, covering all jurisdictions.
In the study, Ms. Townsend and her colleagues compared the rates of donors who were deferred before and after Arizona and California were added to the list of approved states, to determine the potential gain in donors with changes in state tattoo licensing regulations.
They analyzed blood centers in California and Arizona before and after implementation of state tattoo regulations, and also screened individuals who had received tattoos in those states with the question: “In the past 12 months have you had a tattoo?” and if the answer was ‘yes,’ if the tattoo was applied by a state regulated facility.
For California, they compared two periods – 3 months before regulations were implemented (February to April of 2015) and 3 months after (February to April of 2016) regulations were implemented. For Arizona, they selected a 4-month period (December 2015 to March 2016) and 4 months afterward (December 2016 to March 2017).
A higher proportion of donors who came to centers to donate blood admitted to having gotten a tattoo within the last 12 months in the postregulatory period in both states. The increase in donors occurred immediately following the addition of both states to the Acceptable States List. Accepted donors increased 13-fold in California and 3-fold in Arizona. The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.
For blood donors who received a tattoo in a regulated state, blood donations were reviewed for the presence of infectious disease markers including HIV, hepatitis B, and hepatitis C. All donors who had received a tattoo in a regulated state tested negative for HIV, HBV, and HCV.
“Roughly one in three people (in the United States) have a tattoo and, of those, about 70% have more than one tattoo. The bottom line is that 45 million Americans have at least one tattoo,” she said. As state regulations adhere to guidelines regarding tattoos and blood donation, the pool of donors increases.
SAN DIEGO – Tattoos are rapidly moving into mainstream America, and as more states regulate tattoo facilities, persons with tattoos can be blood donors without compromising patient safety, Mary Townsend of Blood Systems Inc. reported at the annual meeting of the American Association of Blood Banks.
“Two big states – Arizona and California – were added to the list of approved states, and we had a gain of 2,216 donors in California during a 3-month period and a gain of 4,035 donors in Arizona over 4 months,” Ms. Townsend said.
Both the AABB and the Food and Drug Administration require a 12-month deferral of donors after they have received tattoos using nonsterile needles or reusable ink. The FDA’s current 2015 guidance also states that tattooed donors can give plasma as soon as the inked area has healed if they reside in a state with applied inspections and licenses for tattoo facilities, and if a sterile needle and ink were used.
Blood Systems monitors state regulations to see if they require tattoo establishments to be licensed and require the use of sterile needles and non-reusable ink. To be considered an approved state, the regulations have to be statewide, covering all jurisdictions.
In the study, Ms. Townsend and her colleagues compared the rates of donors who were deferred before and after Arizona and California were added to the list of approved states, to determine the potential gain in donors with changes in state tattoo licensing regulations.
They analyzed blood centers in California and Arizona before and after implementation of state tattoo regulations, and also screened individuals who had received tattoos in those states with the question: “In the past 12 months have you had a tattoo?” and if the answer was ‘yes,’ if the tattoo was applied by a state regulated facility.
For California, they compared two periods – 3 months before regulations were implemented (February to April of 2015) and 3 months after (February to April of 2016) regulations were implemented. For Arizona, they selected a 4-month period (December 2015 to March 2016) and 4 months afterward (December 2016 to March 2017).
A higher proportion of donors who came to centers to donate blood admitted to having gotten a tattoo within the last 12 months in the postregulatory period in both states. The increase in donors occurred immediately following the addition of both states to the Acceptable States List. Accepted donors increased 13-fold in California and 3-fold in Arizona. The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.
For blood donors who received a tattoo in a regulated state, blood donations were reviewed for the presence of infectious disease markers including HIV, hepatitis B, and hepatitis C. All donors who had received a tattoo in a regulated state tested negative for HIV, HBV, and HCV.
“Roughly one in three people (in the United States) have a tattoo and, of those, about 70% have more than one tattoo. The bottom line is that 45 million Americans have at least one tattoo,” she said. As state regulations adhere to guidelines regarding tattoos and blood donation, the pool of donors increases.
AT AABB 2017
Key clinical point:
Major finding: The absolute number of accepted donors with tattoos rose from 13 to 567 in California and from 151 to 1,496 in Arizona, which represented an annual potential gain of 2,216 and 4,035 additional blood donations.
Data source: An analysis of blood centers in California and Arizona before and after state tattoo regulations were implemented.
Disclosures: Dr. Townsend has no disclosures.
Still too early to determine impact of 1-year deferral for MSM blood donors
SAN DIEGO – It’s still too early to assess the impact of new guidelines for blood donation by men who have had sex with men, Brian S. Custer, PhD, MPH, of Blood Systems Research Institute, San Francisco, said at the annual meeting of the American Association of Blood Banks.
In 2015, the U.S. Food and Drug Administration lifted its lifetime ban on blood donations by men who have sex with men (MSM) and changed it to a 1-year deferral policy. Based on this new guidance, many U.S. blood centers moved from an indefinite deferral for any man who reported having had sex with a man since 1977 to a 1-year deferral from last sexual contact with a man.
In their study, Dr. Custer and his colleagues assessed the impact of the change in policy on donors and whether there was any early evidence of a change in risk to blood recipients.
At their center, the 1-year deferral was implemented on Aug. 29, 2016. On the health questionnaire that potential donors must complete, males are now asked two questions – one regarding sexual contact with men in the previous 12 months, and another about sex with men since 1977.
The rates of deferral were evaluated in two 7-month periods before and after the policy change (September 2015-March 2016 and September 2016-March 2017). They also looked at donor requests to be reinstated in lieu of the new policy, along with infectious disease marker test results in accepted donors.
In 272,306 interviews conducted before the policy change, 408 men responded yes to having sex with men since 1977 and 370 were deferred.
For the 252,395 interviews conducted after the policy change, 245 men answered yes to having sexual contact with men in the previous 12 months, and 245 were deferred.
Some of the men who reported having sex with men before the policy change were evaluated and accepted as donors. Overall, the donor acceptance rate was 9.3% during the period before the policy change, and 64.2% for the period after the policy change.
“Only 67 men requested to be reinstated and have been reinstated, and 39 returned to donate. There have been 59 successful donations to date,” said Dr. Custer.
Some of the reinstated donors were deferred for reasons similar to those for deferral of donors who are not men who have sex with men. Although it is still too early to draw any conclusions, Dr. Custer noted that they are being cautious, because infectious markers still are running a little higher among male donors with a history of having sex with men and donors without such a history.
SAN DIEGO – It’s still too early to assess the impact of new guidelines for blood donation by men who have had sex with men, Brian S. Custer, PhD, MPH, of Blood Systems Research Institute, San Francisco, said at the annual meeting of the American Association of Blood Banks.
In 2015, the U.S. Food and Drug Administration lifted its lifetime ban on blood donations by men who have sex with men (MSM) and changed it to a 1-year deferral policy. Based on this new guidance, many U.S. blood centers moved from an indefinite deferral for any man who reported having had sex with a man since 1977 to a 1-year deferral from last sexual contact with a man.
In their study, Dr. Custer and his colleagues assessed the impact of the change in policy on donors and whether there was any early evidence of a change in risk to blood recipients.
At their center, the 1-year deferral was implemented on Aug. 29, 2016. On the health questionnaire that potential donors must complete, males are now asked two questions – one regarding sexual contact with men in the previous 12 months, and another about sex with men since 1977.
The rates of deferral were evaluated in two 7-month periods before and after the policy change (September 2015-March 2016 and September 2016-March 2017). They also looked at donor requests to be reinstated in lieu of the new policy, along with infectious disease marker test results in accepted donors.
In 272,306 interviews conducted before the policy change, 408 men responded yes to having sex with men since 1977 and 370 were deferred.
For the 252,395 interviews conducted after the policy change, 245 men answered yes to having sexual contact with men in the previous 12 months, and 245 were deferred.
Some of the men who reported having sex with men before the policy change were evaluated and accepted as donors. Overall, the donor acceptance rate was 9.3% during the period before the policy change, and 64.2% for the period after the policy change.
“Only 67 men requested to be reinstated and have been reinstated, and 39 returned to donate. There have been 59 successful donations to date,” said Dr. Custer.
Some of the reinstated donors were deferred for reasons similar to those for deferral of donors who are not men who have sex with men. Although it is still too early to draw any conclusions, Dr. Custer noted that they are being cautious, because infectious markers still are running a little higher among male donors with a history of having sex with men and donors without such a history.
SAN DIEGO – It’s still too early to assess the impact of new guidelines for blood donation by men who have had sex with men, Brian S. Custer, PhD, MPH, of Blood Systems Research Institute, San Francisco, said at the annual meeting of the American Association of Blood Banks.
In 2015, the U.S. Food and Drug Administration lifted its lifetime ban on blood donations by men who have sex with men (MSM) and changed it to a 1-year deferral policy. Based on this new guidance, many U.S. blood centers moved from an indefinite deferral for any man who reported having had sex with a man since 1977 to a 1-year deferral from last sexual contact with a man.
In their study, Dr. Custer and his colleagues assessed the impact of the change in policy on donors and whether there was any early evidence of a change in risk to blood recipients.
At their center, the 1-year deferral was implemented on Aug. 29, 2016. On the health questionnaire that potential donors must complete, males are now asked two questions – one regarding sexual contact with men in the previous 12 months, and another about sex with men since 1977.
The rates of deferral were evaluated in two 7-month periods before and after the policy change (September 2015-March 2016 and September 2016-March 2017). They also looked at donor requests to be reinstated in lieu of the new policy, along with infectious disease marker test results in accepted donors.
In 272,306 interviews conducted before the policy change, 408 men responded yes to having sex with men since 1977 and 370 were deferred.
For the 252,395 interviews conducted after the policy change, 245 men answered yes to having sexual contact with men in the previous 12 months, and 245 were deferred.
Some of the men who reported having sex with men before the policy change were evaluated and accepted as donors. Overall, the donor acceptance rate was 9.3% during the period before the policy change, and 64.2% for the period after the policy change.
“Only 67 men requested to be reinstated and have been reinstated, and 39 returned to donate. There have been 59 successful donations to date,” said Dr. Custer.
Some of the reinstated donors were deferred for reasons similar to those for deferral of donors who are not men who have sex with men. Although it is still too early to draw any conclusions, Dr. Custer noted that they are being cautious, because infectious markers still are running a little higher among male donors with a history of having sex with men and donors without such a history.
AT AABB2017
Key clinical point:
Major finding: Of 370 men deferred for blood donation because of ever having sex with a man since 1977, 67 have requested to be reinstated as donors under the new 1-year deferral policy and 39 returned to donate blood.
Data source: 272,306 interviews conducted before the policy change, and 252,395 interviews conducted after the policy change, at Blood Systems Research Institute.
Disclosures: Dr. Custer had no relevant financial disclosures.
Measures needed to identify past pregnancy in transgender male blood donors
SAN DIEGO –
In study results presented at the annual meeting of the American Association of Blood Banks, 3% of transgender males who were identified as such reported a prior history of pregnancy. Importantly, this pregnancy history may not be divulged unless transgender males are asked “female” questions, said Kathleen M. Grima, MD, executive medical officer at the American Red Cross and medical director of the blood bank at the Brooklyn Hospital Center, New York.
Several studies have suggested that blood from ever-pregnant female donors can present increased risks to male recipients. Research also has suggested that antibodies or other immune system factors that women develop when pregnant could trigger transfusion-related acute lung injury (TRALI), a serious inflammatory reaction that can result in death, in male blood-transfusion recipients.
For this reason, it is important to have pregnancy histories from blood donors, and obtaining those histories from transgender males “presents a challenge for blood centers,” she said. “At our center, when a donor requests a gender change from female to male, an HLA test is requested for the next donation.” But as first-time donors are qualified based on their stated gender, transgender donors who have been pregnant will not be identified unless they volunteer the information or are asked about their pregnancy history.
The AABB recommends that a facility can perform HLA testing on all apheresis plasma donors and all whole blood donors whose units are intended for production into plasma components or, as an alternative, obtain a pregnancy history from all female donors and perform HLA typing only on women with a history of one or more full-term pregnancies.
Dr. Grima explained that, prior to the implementation of the Food and Drug Administration’s “final rule” on requirements for blood and blood components, blood centers asked donors to identify their birth gender to determine eligibility. If gender had changed, the donor was then asked to answer both the male and female questions. The FDA’s final rule now allows blood centers to accept the donor’s stated gender and eligibility can be determined based on that gender.
Dr. Grima and her colleagues conducted a review to determine the number of transgender males who were actively donating with a large blood center and to assess the risk of failing to ask a transgender male donor about pregnancy.
From 2013 to 2015, there were 121 female donors who had changed their gender to male and 60 male donors who had changed their gender to female. Of this group, seven (6%) transgender male donors (female at birth) stated at one of their donations that they had a pregnancy history; three were apheresis donors who had been tested for HLA antibodies (one was positive and two negative). The other four were whole blood donors and had not been tested.
After 2016, donors self-identified their gender, and 326 had requested a gender change from female to male. Of this group, 5 (1.5%) answered yes to pregnancy questions, 56 said no, and 265 did not respond.
“In our system, if a donor identifies as a male, then they only see male questions,” she pointed out. The center subsequently added in a test for HLA antibodies, and 101 donors were tested. Of this group, 13 (13%) tested positive; 2 had answered yes to pregnancy, 4 answered no, and 7 did not respond to the pregnancy question.
Combining the two cohorts, there were 447 transgender males who were identified; 12 (3%) responded yes to pregnancy, and 5 (1%) tested positive for HLA antibodies.
“We are continuing to add the HLA test,” said Dr. Grima. “I’m not sure this is the best [approach], but we will see over time.”
But if a donor comes in for the first time or identifies as a male or transgender male, they won’t be tested, and this is an opportunity that will be missed, she added. “Another option is to ask all donors if they have been pregnant or continue to ask donors their birth gender and then require that they answer both the male and female questions.”
Dr. Grima had no financial disclosures.
SAN DIEGO –
In study results presented at the annual meeting of the American Association of Blood Banks, 3% of transgender males who were identified as such reported a prior history of pregnancy. Importantly, this pregnancy history may not be divulged unless transgender males are asked “female” questions, said Kathleen M. Grima, MD, executive medical officer at the American Red Cross and medical director of the blood bank at the Brooklyn Hospital Center, New York.
Several studies have suggested that blood from ever-pregnant female donors can present increased risks to male recipients. Research also has suggested that antibodies or other immune system factors that women develop when pregnant could trigger transfusion-related acute lung injury (TRALI), a serious inflammatory reaction that can result in death, in male blood-transfusion recipients.
For this reason, it is important to have pregnancy histories from blood donors, and obtaining those histories from transgender males “presents a challenge for blood centers,” she said. “At our center, when a donor requests a gender change from female to male, an HLA test is requested for the next donation.” But as first-time donors are qualified based on their stated gender, transgender donors who have been pregnant will not be identified unless they volunteer the information or are asked about their pregnancy history.
The AABB recommends that a facility can perform HLA testing on all apheresis plasma donors and all whole blood donors whose units are intended for production into plasma components or, as an alternative, obtain a pregnancy history from all female donors and perform HLA typing only on women with a history of one or more full-term pregnancies.
Dr. Grima explained that, prior to the implementation of the Food and Drug Administration’s “final rule” on requirements for blood and blood components, blood centers asked donors to identify their birth gender to determine eligibility. If gender had changed, the donor was then asked to answer both the male and female questions. The FDA’s final rule now allows blood centers to accept the donor’s stated gender and eligibility can be determined based on that gender.
Dr. Grima and her colleagues conducted a review to determine the number of transgender males who were actively donating with a large blood center and to assess the risk of failing to ask a transgender male donor about pregnancy.
From 2013 to 2015, there were 121 female donors who had changed their gender to male and 60 male donors who had changed their gender to female. Of this group, seven (6%) transgender male donors (female at birth) stated at one of their donations that they had a pregnancy history; three were apheresis donors who had been tested for HLA antibodies (one was positive and two negative). The other four were whole blood donors and had not been tested.
After 2016, donors self-identified their gender, and 326 had requested a gender change from female to male. Of this group, 5 (1.5%) answered yes to pregnancy questions, 56 said no, and 265 did not respond.
“In our system, if a donor identifies as a male, then they only see male questions,” she pointed out. The center subsequently added in a test for HLA antibodies, and 101 donors were tested. Of this group, 13 (13%) tested positive; 2 had answered yes to pregnancy, 4 answered no, and 7 did not respond to the pregnancy question.
Combining the two cohorts, there were 447 transgender males who were identified; 12 (3%) responded yes to pregnancy, and 5 (1%) tested positive for HLA antibodies.
“We are continuing to add the HLA test,” said Dr. Grima. “I’m not sure this is the best [approach], but we will see over time.”
But if a donor comes in for the first time or identifies as a male or transgender male, they won’t be tested, and this is an opportunity that will be missed, she added. “Another option is to ask all donors if they have been pregnant or continue to ask donors their birth gender and then require that they answer both the male and female questions.”
Dr. Grima had no financial disclosures.
SAN DIEGO –
In study results presented at the annual meeting of the American Association of Blood Banks, 3% of transgender males who were identified as such reported a prior history of pregnancy. Importantly, this pregnancy history may not be divulged unless transgender males are asked “female” questions, said Kathleen M. Grima, MD, executive medical officer at the American Red Cross and medical director of the blood bank at the Brooklyn Hospital Center, New York.
Several studies have suggested that blood from ever-pregnant female donors can present increased risks to male recipients. Research also has suggested that antibodies or other immune system factors that women develop when pregnant could trigger transfusion-related acute lung injury (TRALI), a serious inflammatory reaction that can result in death, in male blood-transfusion recipients.
For this reason, it is important to have pregnancy histories from blood donors, and obtaining those histories from transgender males “presents a challenge for blood centers,” she said. “At our center, when a donor requests a gender change from female to male, an HLA test is requested for the next donation.” But as first-time donors are qualified based on their stated gender, transgender donors who have been pregnant will not be identified unless they volunteer the information or are asked about their pregnancy history.
The AABB recommends that a facility can perform HLA testing on all apheresis plasma donors and all whole blood donors whose units are intended for production into plasma components or, as an alternative, obtain a pregnancy history from all female donors and perform HLA typing only on women with a history of one or more full-term pregnancies.
Dr. Grima explained that, prior to the implementation of the Food and Drug Administration’s “final rule” on requirements for blood and blood components, blood centers asked donors to identify their birth gender to determine eligibility. If gender had changed, the donor was then asked to answer both the male and female questions. The FDA’s final rule now allows blood centers to accept the donor’s stated gender and eligibility can be determined based on that gender.
Dr. Grima and her colleagues conducted a review to determine the number of transgender males who were actively donating with a large blood center and to assess the risk of failing to ask a transgender male donor about pregnancy.
From 2013 to 2015, there were 121 female donors who had changed their gender to male and 60 male donors who had changed their gender to female. Of this group, seven (6%) transgender male donors (female at birth) stated at one of their donations that they had a pregnancy history; three were apheresis donors who had been tested for HLA antibodies (one was positive and two negative). The other four were whole blood donors and had not been tested.
After 2016, donors self-identified their gender, and 326 had requested a gender change from female to male. Of this group, 5 (1.5%) answered yes to pregnancy questions, 56 said no, and 265 did not respond.
“In our system, if a donor identifies as a male, then they only see male questions,” she pointed out. The center subsequently added in a test for HLA antibodies, and 101 donors were tested. Of this group, 13 (13%) tested positive; 2 had answered yes to pregnancy, 4 answered no, and 7 did not respond to the pregnancy question.
Combining the two cohorts, there were 447 transgender males who were identified; 12 (3%) responded yes to pregnancy, and 5 (1%) tested positive for HLA antibodies.
“We are continuing to add the HLA test,” said Dr. Grima. “I’m not sure this is the best [approach], but we will see over time.”
But if a donor comes in for the first time or identifies as a male or transgender male, they won’t be tested, and this is an opportunity that will be missed, she added. “Another option is to ask all donors if they have been pregnant or continue to ask donors their birth gender and then require that they answer both the male and female questions.”
Dr. Grima had no financial disclosures.
AT AABB17
Key clinical point: First-time transgender male donors with a history of pregnancy will not be identified, and HLA testing might not be performed unless these donors volunteer this information.
Major finding: Among 447 transgender males who were identified, 3% had been pregnant, and 1% tested positive for HLA antibodies.
Data source: A review of data from the blood bank at the Brooklyn Hospital Center, New York.
Disclosures: Dr. Grima had no financial disclosures.
RBCs from previously pregnant women linked to increased mortality in men
By contrast, all-cause mortality was not higher in female transplant recipients who received transfusions from previously pregnant females and was not higher in male or female recipients of transfusions from never-pregnant female donors.
The results need to be replicated in prospective trials. “Further research is needed to replicate these findings, determine their clinical significance, and identify the underlying mechanism,” wrote Camila Caram-Deelder, MSc, of the Center for Clinical Transfusion Research, Sanquin Research, Leiden, the Netherlands, and her coauthors (JAMA. 2017;318[15]:1471-78).
The association “may be related to either immunologic phenomena or other mechanisms,” the investigators said. The cause of increased mortality also could be some difference in iron status between the previously pregnant female donors and male donors.
Ms. Caram-Deelder and her associates studied first-time transfusion recipients treated between 2005 and 2015 at six hospitals in the Netherlands. A total of 42,132 patients received 106,641 units of red blood cells. Among this full cohort, 31,118 patients (52% female) received 59,320 units of red blood cells exclusively from one of the three types of donor (88% male, 6% ever-pregnant female, and 6% never-pregnant female) and were followed up for a median of 245 days. During that time, 13% of the cohort died.
For the 14,995 male recipients in the no-donor-mixture cohort, 13% died during follow-up. The hazard ratio for death after 1 additional unit of red blood cells from a never-pregnant female donor, compared with a unit from a male donor, was 0.93 (95% CI, 0.81 to 1.06) for male recipients and 1.01 (95% CI, 0.88 to 1.15) for female recipients. This difference was not significant. Alternatively, for male recipients the HR for death after 1 additional unit of red blood cells from an ever-pregnant female donor, compared with a unit from a male donor, was 1.13 (95% CI, 1.01 to 1.26). The difference was statistically significant (P = .03).
Of the 16,123 female recipients in the no-donor-mixture cohort, 12% died during follow-up. Mortality rates for an ever-pregnant female donor vs. a male donor were 74 and 62 per 1,000 person-years (HR, 0.99; 95% CI, 0.87 to 1.13); for a never-pregnant female donor vs. a male donor, mortality rates were 74 and 62 per 1,000 person-years (HR, 1.01; 95% CI, 0.88-1.15). The difference was not significant.
The highest HRs for death after transfusion of red blood cells from ever-pregnant female donors were observed in male recipients 50 years and younger.
Study funding came from the Dutch Ministry of Health, Welfare and Sports. One investigator in the study reported receiving a speaking fee from Vifor Pharma and serving on the advisory councils of Novartis and Amgen Science.
The provocative finding that men have an increased mortality risk if they receive red blood cell transplants from women with a history of pregnancy could have significant practical implications if proven true in subsequent studies.
Because of the complex methodology of the study, alternative explanations for the association should be considered.
The differences in mortality seem to increase 1 year or more following the transfusion, suggesting that the trigger may be an immunologic mechanism based on maternal immunization to paternal antigens, but until prospective studies confirm that a donor’s sex and pregnancy status are associated with mortality after transplant, “appropriate and conservative use of blood products continues to be the gold standard for safe transfusion.”
Ritchard G. Cable, MD, is with American Red Cross Blood Services, Connecticut Region, Farmington. Gustaf Edgren, MD, PhD, is with the department of hematology at Karolinska University Hospital, Stockholm. These comments are based on their accompanying editorial (JAMA. 2017 Oct 17;318[15]:1445-7). They reported no financial conflicts of interest.
The provocative finding that men have an increased mortality risk if they receive red blood cell transplants from women with a history of pregnancy could have significant practical implications if proven true in subsequent studies.
Because of the complex methodology of the study, alternative explanations for the association should be considered.
The differences in mortality seem to increase 1 year or more following the transfusion, suggesting that the trigger may be an immunologic mechanism based on maternal immunization to paternal antigens, but until prospective studies confirm that a donor’s sex and pregnancy status are associated with mortality after transplant, “appropriate and conservative use of blood products continues to be the gold standard for safe transfusion.”
Ritchard G. Cable, MD, is with American Red Cross Blood Services, Connecticut Region, Farmington. Gustaf Edgren, MD, PhD, is with the department of hematology at Karolinska University Hospital, Stockholm. These comments are based on their accompanying editorial (JAMA. 2017 Oct 17;318[15]:1445-7). They reported no financial conflicts of interest.
The provocative finding that men have an increased mortality risk if they receive red blood cell transplants from women with a history of pregnancy could have significant practical implications if proven true in subsequent studies.
Because of the complex methodology of the study, alternative explanations for the association should be considered.
The differences in mortality seem to increase 1 year or more following the transfusion, suggesting that the trigger may be an immunologic mechanism based on maternal immunization to paternal antigens, but until prospective studies confirm that a donor’s sex and pregnancy status are associated with mortality after transplant, “appropriate and conservative use of blood products continues to be the gold standard for safe transfusion.”
Ritchard G. Cable, MD, is with American Red Cross Blood Services, Connecticut Region, Farmington. Gustaf Edgren, MD, PhD, is with the department of hematology at Karolinska University Hospital, Stockholm. These comments are based on their accompanying editorial (JAMA. 2017 Oct 17;318[15]:1445-7). They reported no financial conflicts of interest.
By contrast, all-cause mortality was not higher in female transplant recipients who received transfusions from previously pregnant females and was not higher in male or female recipients of transfusions from never-pregnant female donors.
The results need to be replicated in prospective trials. “Further research is needed to replicate these findings, determine their clinical significance, and identify the underlying mechanism,” wrote Camila Caram-Deelder, MSc, of the Center for Clinical Transfusion Research, Sanquin Research, Leiden, the Netherlands, and her coauthors (JAMA. 2017;318[15]:1471-78).
The association “may be related to either immunologic phenomena or other mechanisms,” the investigators said. The cause of increased mortality also could be some difference in iron status between the previously pregnant female donors and male donors.
Ms. Caram-Deelder and her associates studied first-time transfusion recipients treated between 2005 and 2015 at six hospitals in the Netherlands. A total of 42,132 patients received 106,641 units of red blood cells. Among this full cohort, 31,118 patients (52% female) received 59,320 units of red blood cells exclusively from one of the three types of donor (88% male, 6% ever-pregnant female, and 6% never-pregnant female) and were followed up for a median of 245 days. During that time, 13% of the cohort died.
For the 14,995 male recipients in the no-donor-mixture cohort, 13% died during follow-up. The hazard ratio for death after 1 additional unit of red blood cells from a never-pregnant female donor, compared with a unit from a male donor, was 0.93 (95% CI, 0.81 to 1.06) for male recipients and 1.01 (95% CI, 0.88 to 1.15) for female recipients. This difference was not significant. Alternatively, for male recipients the HR for death after 1 additional unit of red blood cells from an ever-pregnant female donor, compared with a unit from a male donor, was 1.13 (95% CI, 1.01 to 1.26). The difference was statistically significant (P = .03).
Of the 16,123 female recipients in the no-donor-mixture cohort, 12% died during follow-up. Mortality rates for an ever-pregnant female donor vs. a male donor were 74 and 62 per 1,000 person-years (HR, 0.99; 95% CI, 0.87 to 1.13); for a never-pregnant female donor vs. a male donor, mortality rates were 74 and 62 per 1,000 person-years (HR, 1.01; 95% CI, 0.88-1.15). The difference was not significant.
The highest HRs for death after transfusion of red blood cells from ever-pregnant female donors were observed in male recipients 50 years and younger.
Study funding came from the Dutch Ministry of Health, Welfare and Sports. One investigator in the study reported receiving a speaking fee from Vifor Pharma and serving on the advisory councils of Novartis and Amgen Science.
By contrast, all-cause mortality was not higher in female transplant recipients who received transfusions from previously pregnant females and was not higher in male or female recipients of transfusions from never-pregnant female donors.
The results need to be replicated in prospective trials. “Further research is needed to replicate these findings, determine their clinical significance, and identify the underlying mechanism,” wrote Camila Caram-Deelder, MSc, of the Center for Clinical Transfusion Research, Sanquin Research, Leiden, the Netherlands, and her coauthors (JAMA. 2017;318[15]:1471-78).
The association “may be related to either immunologic phenomena or other mechanisms,” the investigators said. The cause of increased mortality also could be some difference in iron status between the previously pregnant female donors and male donors.
Ms. Caram-Deelder and her associates studied first-time transfusion recipients treated between 2005 and 2015 at six hospitals in the Netherlands. A total of 42,132 patients received 106,641 units of red blood cells. Among this full cohort, 31,118 patients (52% female) received 59,320 units of red blood cells exclusively from one of the three types of donor (88% male, 6% ever-pregnant female, and 6% never-pregnant female) and were followed up for a median of 245 days. During that time, 13% of the cohort died.
For the 14,995 male recipients in the no-donor-mixture cohort, 13% died during follow-up. The hazard ratio for death after 1 additional unit of red blood cells from a never-pregnant female donor, compared with a unit from a male donor, was 0.93 (95% CI, 0.81 to 1.06) for male recipients and 1.01 (95% CI, 0.88 to 1.15) for female recipients. This difference was not significant. Alternatively, for male recipients the HR for death after 1 additional unit of red blood cells from an ever-pregnant female donor, compared with a unit from a male donor, was 1.13 (95% CI, 1.01 to 1.26). The difference was statistically significant (P = .03).
Of the 16,123 female recipients in the no-donor-mixture cohort, 12% died during follow-up. Mortality rates for an ever-pregnant female donor vs. a male donor were 74 and 62 per 1,000 person-years (HR, 0.99; 95% CI, 0.87 to 1.13); for a never-pregnant female donor vs. a male donor, mortality rates were 74 and 62 per 1,000 person-years (HR, 1.01; 95% CI, 0.88-1.15). The difference was not significant.
The highest HRs for death after transfusion of red blood cells from ever-pregnant female donors were observed in male recipients 50 years and younger.
Study funding came from the Dutch Ministry of Health, Welfare and Sports. One investigator in the study reported receiving a speaking fee from Vifor Pharma and serving on the advisory councils of Novartis and Amgen Science.
FROM JAMA
Key clinical point: Receiving a red blood cell transfusion from a female donor with any history of pregnancy was associated with increased mortality in men, but not in women.
Major finding: Among men, all-cause mortality after transfusion from an ever-pregnant female donor vs. a male donor was 101 vs. 80 deaths per 1000 person-years (hazard ratio, 1.13; 95% confidence interval, 1.01-1.26).
Data source: Retrospective cohort study of 31,118 patients who received red blood cell transfusions exclusively from one of the three types of donor – 88% male, 6% ever-pregnant female, and 6% never-pregnant female – at one of six Dutch hospitals.
Disclosures: Study funding came from the Dutch Ministry of Health, Welfare and Sports. One investigator in the study reported receiving a speaking fee from Vifor Pharma and serving on the advisory councils of Novartis and Amgen Science.
FDA approves test to screen donated blood for Zika virus
The cobas Zika test has been approved for detecting the virus in whole blood, blood components, and donated organs, the U.S. Food and Drug Administration announced in a press release.
“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply.”
In August 2016, the FDA issued a final guidance document recommending that all individual units of whole blood and blood components be screened with an investigational blood screening test available under an investigational new drug application. Data obtained on the cobas Zika test under its investigational new drug application and from additional studies performed by the manufacturer demonstrated that the cobas Zika test is effective. Testing individual samples from blood donations at five external laboratory sites resulted in a clinical specificity exceeding 99%.
The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems. The cobas Zika test, cobas 6800, and cobas 8800 systems are manufactured by Roche Molecular Systems.
The cobas Zika test has been approved for detecting the virus in whole blood, blood components, and donated organs, the U.S. Food and Drug Administration announced in a press release.
“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply.”
In August 2016, the FDA issued a final guidance document recommending that all individual units of whole blood and blood components be screened with an investigational blood screening test available under an investigational new drug application. Data obtained on the cobas Zika test under its investigational new drug application and from additional studies performed by the manufacturer demonstrated that the cobas Zika test is effective. Testing individual samples from blood donations at five external laboratory sites resulted in a clinical specificity exceeding 99%.
The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems. The cobas Zika test, cobas 6800, and cobas 8800 systems are manufactured by Roche Molecular Systems.
The cobas Zika test has been approved for detecting the virus in whole blood, blood components, and donated organs, the U.S. Food and Drug Administration announced in a press release.
“Today’s action represents the first approval of a Zika virus detection test for use with screening the nation’s blood supply,” Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said in a press release. “Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply.”
In August 2016, the FDA issued a final guidance document recommending that all individual units of whole blood and blood components be screened with an investigational blood screening test available under an investigational new drug application. Data obtained on the cobas Zika test under its investigational new drug application and from additional studies performed by the manufacturer demonstrated that the cobas Zika test is effective. Testing individual samples from blood donations at five external laboratory sites resulted in a clinical specificity exceeding 99%.
The cobas Zika test is intended for use on the fully automated cobas 6800 and cobas 8800 systems. The cobas Zika test, cobas 6800, and cobas 8800 systems are manufactured by Roche Molecular Systems.