Think before reversing anticoagulants

Medicolegal review has the opportunity to become the morbidity and mortality conference of the modern era. Each month, this column presents a case vignette that explores some aspect of medicine and the applicable standard of care. I hope to bring a critical emphasis on how physicians think and make decisions, with the ultimate goal of highlighting the lesson to be learned by all.

The more we share in our collective failures, the less likely we are to repeat those same mistakes.

Mr. B was a 76-year-old man with a 2- to 3-year history of umbilical hernia. He presented to the emergency department at 10 p.m. on a Sunday night with periumbilical abdominal pain. The pain began the prior evening when he was lifting something heavy. The pain was rated at a 5/10 intensity and had been fairly constant ever since. There was some nausea with emesis. Mr. B denied bowel motions for the past 2 days.

Mr. B had a past medical history significant for hypertension, hyperlipidemia, asthma, and chronic atrial fibrillation. His medications included simvastatin, Coumadin, verapamil, and as needed albuterol.

On examination, Mr. B had normal vital signs but he looked uncomfortable. He had an umbilical hernia that was red and tender. A complete blood count was normal. A complete metabolic profile was normal except for a potassium of 3.3 mEq/dL. An acute abdominal series was normal.

Mr. B was treated with an intravenous opiate and reported feeling a little better, but he was still having pain. The emergency department physician handed off Mr. B to Dr. Weekend-Nocturnist with a diagnosis of "incarcerated hernia." Dr. Weekend-Nocturnist admitted Mr. B to telemetry and initiated IV fluids, potassium replacement, and IV analgesia. An amylase/lipase, coagulation studies, and a CT of the abdomen and pelvis were included in the admission orders. At 3 a.m., the amylase/lipase were reported as normal and the INR was 1.97. The CT was complete shortly thereafter, and the result is transcribed:

"Impression: small bowel obstruction of the ileum due to an anterior wall hernia; there is distal small bowel decompression. Luminal contrast is only seen within the proximal small bowel. There is no evidence of bowel incarceration, abscess, perforation, or fluid collection."

At 7 a.m., Dr. Weekend-Nocturnist transferred care of Mr. B to Dr. Daytime-Hospitalist. At 9:30 on Monday morning, Dr. Daytime-Hospitalist saw Mr. B on rounds. Mr. B complained of some nausea, but his vital signs remained normal. The abdominal exam confirmed an 8-cm, tender, nonreducible umbilical mass. Dr. Daytime-Hospitalist ordered a routine surgical consult, along with 5 mg of subcutaneous vitamin K, 4 units of fresh frozen plasma, and an unfractionated heparin drip according to a weight-based dosing nomogram. Dr. Daytime-Hospitalist documented informed consent for blood products as "risks, benefits, and alternatives discussed."

The first unit of fresh frozen plasma arrived at the floor at noon. After 50 cc of FFP was transfused, Mr. B turned bright red and complained of difficulty breathing. Within 30 seconds, he was unconscious with no spontaneous respirations. A code blue was called. He was intubated and resuscitated for 17 minutes until he was pronounced dead at 12:50 p.m. No autopsy was performed. Cross-match testing on Mr. B’s blood and the FFP did not reveal ABO incompatibility.

Complaint

Approximately 1 year later, Dr. Daytime-Hospitalist was sued by the widow of Mr. B for wrongful death. The estate of Mr. B asserted that Dr. Daytime-Hospitalist did not have a reasonable indication for the use of FFP in this case, and thus the informed consent was nullified. The plaintiff further asserted that the FFP caused transfusion-related lung injury and was the proximate cause of Mr. B’s death.

The plaintiff concluded that were it not for the negligent actions of Dr. Daytime-Hospitalist, Mr. B would be alive today.

Scientific principles

FFP is indicated for "bleeding conditions." This includes but is not limited to liver disease or failure, dilutional coagulopathy from massive red blood cell transfusion, severe disseminated intravascular coagulation (DIC) refractory to prothrombinase complex concentrates or cryoprecipitate, warfarin overdose, and vitamin K deficiency.

FFP is also indicated to reverse the effects of warfarin in the setting of urgent or emergent surgery. The risks of FFP include but are not limited to blood-borne infection (hepatitis B and C, HTLV, and HIV), volume overload, febrile reactions, anaphylaxis (IgA individuals, ABO incompatibility), and transfusion-related lung injury (TRALI).

Complaint rebuttal and discussion

Dr. Daytime-Hospitalist argued that the FFP was indicated for urgent or emergent surgery in the setting of incarcerated umbilical hernia, and that this benefit outweighed the potential risks. Dr. Daytime-Hospitalist further argued that Mr. B was aware of the risk and wished to proceed. Finally, the defendant also argued that the cause of death was speculative and was unlikely to be related to the administration of FFP. However, in this case Dr. Daytime-Hospitalist ordered the surgical consult as routine, not stat. The CT of the abdomen and pelvis did not support an incarcerated hernia, nor did the physical examination support an urgent or emergent surgical need. Also, FFP has a time-limited clinical benefit due to the half-lives of the coagulation factors in the blood product.

Assuming that Dr. Daytime-Hospitalist was correct and urgent or emergent surgery was necessary, he never spoke to the surgeon on call prior to Mr. B’s death. Dr. Daytime-Hospitalist would need to know the timing of the surgical intervention to know when to give the FFP. The plaintiff argued that the informed consent process requires accurate information to be provided before any consent can be given. In this case, there was never any indication to give the FFP, and whatever Dr. Daytime-Hospitalist told Mr. B was not accurate as a result.

Finally, to argue that the cause of death was not related to FFP, you would have to assert that Mr. B would have had shortness of breath followed by a respiratory arrest and death at 12:50 p.m. regardless of whether FFP was given or not. TRALI is a rare but known complication of FFP, and there was not an alternative explanation as likely as TRALI to explain the cause of death.

Conclusion

Anticoagulation poses significant challenges for the hospitalist.

Cessation of anticoagulation puts our patients at risk for thromboses, but to continue anticoagulation throughout a hospital stay increases the risk of bleeding, along with our ability to perform procedures or otherwise react to changes in clinical condition. Hospitalists must remember that anticoagulation reversal with blood products should not be taken lightly, and should never be used for expediency or "just in case."

In this case, Dr. Daytime-Hospitalist was "prepping" the patient for a presumed surgery. However, the use of blood products should have waited until the need and timing of the surgery were further defined. This case was ultimately settled in favor of the plaintiff for an undisclosed amount.

Dr. Michota is director of academic affairs in the hospital medicine department at the Cleveland Clinic and medical editor of Hospitalist News. He reported having no relevant financial conflicts.

Medicolegal review has the opportunity to become the morbidity and mortality conference of the modern era. Each month, this column presents a case vignette that explores some aspect of medicine and the applicable standard of care. I hope to bring a critical emphasis on how physicians think and make decisions, with the ultimate goal of highlighting the lesson to be learned by all.

The more we share in our collective failures, the less likely we are to repeat those same mistakes.

Mr. B was a 76-year-old man with a 2- to 3-year history of umbilical hernia. He presented to the emergency department at 10 p.m. on a Sunday night with periumbilical abdominal pain. The pain began the prior evening when he was lifting something heavy. The pain was rated at a 5/10 intensity and had been fairly constant ever since. There was some nausea with emesis. Mr. B denied bowel motions for the past 2 days.

Mr. B had a past medical history significant for hypertension, hyperlipidemia, asthma, and chronic atrial fibrillation. His medications included simvastatin, Coumadin, verapamil, and as needed albuterol.

On examination, Mr. B had normal vital signs but he looked uncomfortable. He had an umbilical hernia that was red and tender. A complete blood count was normal. A complete metabolic profile was normal except for a potassium of 3.3 mEq/dL. An acute abdominal series was normal.

Mr. B was treated with an intravenous opiate and reported feeling a little better, but he was still having pain. The emergency department physician handed off Mr. B to Dr. Weekend-Nocturnist with a diagnosis of "incarcerated hernia." Dr. Weekend-Nocturnist admitted Mr. B to telemetry and initiated IV fluids, potassium replacement, and IV analgesia. An amylase/lipase, coagulation studies, and a CT of the abdomen and pelvis were included in the admission orders. At 3 a.m., the amylase/lipase were reported as normal and the INR was 1.97. The CT was complete shortly thereafter, and the result is transcribed:

"Impression: small bowel obstruction of the ileum due to an anterior wall hernia; there is distal small bowel decompression. Luminal contrast is only seen within the proximal small bowel. There is no evidence of bowel incarceration, abscess, perforation, or fluid collection."

At 7 a.m., Dr. Weekend-Nocturnist transferred care of Mr. B to Dr. Daytime-Hospitalist. At 9:30 on Monday morning, Dr. Daytime-Hospitalist saw Mr. B on rounds. Mr. B complained of some nausea, but his vital signs remained normal. The abdominal exam confirmed an 8-cm, tender, nonreducible umbilical mass. Dr. Daytime-Hospitalist ordered a routine surgical consult, along with 5 mg of subcutaneous vitamin K, 4 units of fresh frozen plasma, and an unfractionated heparin drip according to a weight-based dosing nomogram. Dr. Daytime-Hospitalist documented informed consent for blood products as "risks, benefits, and alternatives discussed."

The first unit of fresh frozen plasma arrived at the floor at noon. After 50 cc of FFP was transfused, Mr. B turned bright red and complained of difficulty breathing. Within 30 seconds, he was unconscious with no spontaneous respirations. A code blue was called. He was intubated and resuscitated for 17 minutes until he was pronounced dead at 12:50 p.m. No autopsy was performed. Cross-match testing on Mr. B’s blood and the FFP did not reveal ABO incompatibility.

Complaint

Approximately 1 year later, Dr. Daytime-Hospitalist was sued by the widow of Mr. B for wrongful death. The estate of Mr. B asserted that Dr. Daytime-Hospitalist did not have a reasonable indication for the use of FFP in this case, and thus the informed consent was nullified. The plaintiff further asserted that the FFP caused transfusion-related lung injury and was the proximate cause of Mr. B’s death.

The plaintiff concluded that were it not for the negligent actions of Dr. Daytime-Hospitalist, Mr. B would be alive today.

Scientific principles

FFP is indicated for "bleeding conditions." This includes but is not limited to liver disease or failure, dilutional coagulopathy from massive red blood cell transfusion, severe disseminated intravascular coagulation (DIC) refractory to prothrombinase complex concentrates or cryoprecipitate, warfarin overdose, and vitamin K deficiency.

FFP is also indicated to reverse the effects of warfarin in the setting of urgent or emergent surgery. The risks of FFP include but are not limited to blood-borne infection (hepatitis B and C, HTLV, and HIV), volume overload, febrile reactions, anaphylaxis (IgA individuals, ABO incompatibility), and transfusion-related lung injury (TRALI).

Complaint rebuttal and discussion

Dr. Daytime-Hospitalist argued that the FFP was indicated for urgent or emergent surgery in the setting of incarcerated umbilical hernia, and that this benefit outweighed the potential risks. Dr. Daytime-Hospitalist further argued that Mr. B was aware of the risk and wished to proceed. Finally, the defendant also argued that the cause of death was speculative and was unlikely to be related to the administration of FFP. However, in this case Dr. Daytime-Hospitalist ordered the surgical consult as routine, not stat. The CT of the abdomen and pelvis did not support an incarcerated hernia, nor did the physical examination support an urgent or emergent surgical need. Also, FFP has a time-limited clinical benefit due to the half-lives of the coagulation factors in the blood product.

Assuming that Dr. Daytime-Hospitalist was correct and urgent or emergent surgery was necessary, he never spoke to the surgeon on call prior to Mr. B’s death. Dr. Daytime-Hospitalist would need to know the timing of the surgical intervention to know when to give the FFP. The plaintiff argued that the informed consent process requires accurate information to be provided before any consent can be given. In this case, there was never any indication to give the FFP, and whatever Dr. Daytime-Hospitalist told Mr. B was not accurate as a result.

Finally, to argue that the cause of death was not related to FFP, you would have to assert that Mr. B would have had shortness of breath followed by a respiratory arrest and death at 12:50 p.m. regardless of whether FFP was given or not. TRALI is a rare but known complication of FFP, and there was not an alternative explanation as likely as TRALI to explain the cause of death.

Conclusion

Anticoagulation poses significant challenges for the hospitalist.

Cessation of anticoagulation puts our patients at risk for thromboses, but to continue anticoagulation throughout a hospital stay increases the risk of bleeding, along with our ability to perform procedures or otherwise react to changes in clinical condition. Hospitalists must remember that anticoagulation reversal with blood products should not be taken lightly, and should never be used for expediency or "just in case."

In this case, Dr. Daytime-Hospitalist was "prepping" the patient for a presumed surgery. However, the use of blood products should have waited until the need and timing of the surgery were further defined. This case was ultimately settled in favor of the plaintiff for an undisclosed amount.

Dr. Michota is director of academic affairs in the hospital medicine department at the Cleveland Clinic and medical editor of Hospitalist News. He reported having no relevant financial conflicts.

Medicolegal review has the opportunity to become the morbidity and mortality conference of the modern era. Each month, this column presents a case vignette that explores some aspect of medicine and the applicable standard of care. I hope to bring a critical emphasis on how physicians think and make decisions, with the ultimate goal of highlighting the lesson to be learned by all.

The more we share in our collective failures, the less likely we are to repeat those same mistakes.

Mr. B was a 76-year-old man with a 2- to 3-year history of umbilical hernia. He presented to the emergency department at 10 p.m. on a Sunday night with periumbilical abdominal pain. The pain began the prior evening when he was lifting something heavy. The pain was rated at a 5/10 intensity and had been fairly constant ever since. There was some nausea with emesis. Mr. B denied bowel motions for the past 2 days.

Mr. B had a past medical history significant for hypertension, hyperlipidemia, asthma, and chronic atrial fibrillation. His medications included simvastatin, Coumadin, verapamil, and as needed albuterol.

On examination, Mr. B had normal vital signs but he looked uncomfortable. He had an umbilical hernia that was red and tender. A complete blood count was normal. A complete metabolic profile was normal except for a potassium of 3.3 mEq/dL. An acute abdominal series was normal.

Mr. B was treated with an intravenous opiate and reported feeling a little better, but he was still having pain. The emergency department physician handed off Mr. B to Dr. Weekend-Nocturnist with a diagnosis of "incarcerated hernia." Dr. Weekend-Nocturnist admitted Mr. B to telemetry and initiated IV fluids, potassium replacement, and IV analgesia. An amylase/lipase, coagulation studies, and a CT of the abdomen and pelvis were included in the admission orders. At 3 a.m., the amylase/lipase were reported as normal and the INR was 1.97. The CT was complete shortly thereafter, and the result is transcribed:

"Impression: small bowel obstruction of the ileum due to an anterior wall hernia; there is distal small bowel decompression. Luminal contrast is only seen within the proximal small bowel. There is no evidence of bowel incarceration, abscess, perforation, or fluid collection."

At 7 a.m., Dr. Weekend-Nocturnist transferred care of Mr. B to Dr. Daytime-Hospitalist. At 9:30 on Monday morning, Dr. Daytime-Hospitalist saw Mr. B on rounds. Mr. B complained of some nausea, but his vital signs remained normal. The abdominal exam confirmed an 8-cm, tender, nonreducible umbilical mass. Dr. Daytime-Hospitalist ordered a routine surgical consult, along with 5 mg of subcutaneous vitamin K, 4 units of fresh frozen plasma, and an unfractionated heparin drip according to a weight-based dosing nomogram. Dr. Daytime-Hospitalist documented informed consent for blood products as "risks, benefits, and alternatives discussed."

The first unit of fresh frozen plasma arrived at the floor at noon. After 50 cc of FFP was transfused, Mr. B turned bright red and complained of difficulty breathing. Within 30 seconds, he was unconscious with no spontaneous respirations. A code blue was called. He was intubated and resuscitated for 17 minutes until he was pronounced dead at 12:50 p.m. No autopsy was performed. Cross-match testing on Mr. B’s blood and the FFP did not reveal ABO incompatibility.

Complaint

Approximately 1 year later, Dr. Daytime-Hospitalist was sued by the widow of Mr. B for wrongful death. The estate of Mr. B asserted that Dr. Daytime-Hospitalist did not have a reasonable indication for the use of FFP in this case, and thus the informed consent was nullified. The plaintiff further asserted that the FFP caused transfusion-related lung injury and was the proximate cause of Mr. B’s death.

The plaintiff concluded that were it not for the negligent actions of Dr. Daytime-Hospitalist, Mr. B would be alive today.

Scientific principles

FFP is indicated for "bleeding conditions." This includes but is not limited to liver disease or failure, dilutional coagulopathy from massive red blood cell transfusion, severe disseminated intravascular coagulation (DIC) refractory to prothrombinase complex concentrates or cryoprecipitate, warfarin overdose, and vitamin K deficiency.

FFP is also indicated to reverse the effects of warfarin in the setting of urgent or emergent surgery. The risks of FFP include but are not limited to blood-borne infection (hepatitis B and C, HTLV, and HIV), volume overload, febrile reactions, anaphylaxis (IgA individuals, ABO incompatibility), and transfusion-related lung injury (TRALI).

Complaint rebuttal and discussion

Dr. Daytime-Hospitalist argued that the FFP was indicated for urgent or emergent surgery in the setting of incarcerated umbilical hernia, and that this benefit outweighed the potential risks. Dr. Daytime-Hospitalist further argued that Mr. B was aware of the risk and wished to proceed. Finally, the defendant also argued that the cause of death was speculative and was unlikely to be related to the administration of FFP. However, in this case Dr. Daytime-Hospitalist ordered the surgical consult as routine, not stat. The CT of the abdomen and pelvis did not support an incarcerated hernia, nor did the physical examination support an urgent or emergent surgical need. Also, FFP has a time-limited clinical benefit due to the half-lives of the coagulation factors in the blood product.

Assuming that Dr. Daytime-Hospitalist was correct and urgent or emergent surgery was necessary, he never spoke to the surgeon on call prior to Mr. B’s death. Dr. Daytime-Hospitalist would need to know the timing of the surgical intervention to know when to give the FFP. The plaintiff argued that the informed consent process requires accurate information to be provided before any consent can be given. In this case, there was never any indication to give the FFP, and whatever Dr. Daytime-Hospitalist told Mr. B was not accurate as a result.

Finally, to argue that the cause of death was not related to FFP, you would have to assert that Mr. B would have had shortness of breath followed by a respiratory arrest and death at 12:50 p.m. regardless of whether FFP was given or not. TRALI is a rare but known complication of FFP, and there was not an alternative explanation as likely as TRALI to explain the cause of death.

Conclusion

Anticoagulation poses significant challenges for the hospitalist.

Cessation of anticoagulation puts our patients at risk for thromboses, but to continue anticoagulation throughout a hospital stay increases the risk of bleeding, along with our ability to perform procedures or otherwise react to changes in clinical condition. Hospitalists must remember that anticoagulation reversal with blood products should not be taken lightly, and should never be used for expediency or "just in case."

In this case, Dr. Daytime-Hospitalist was "prepping" the patient for a presumed surgery. However, the use of blood products should have waited until the need and timing of the surgery were further defined. This case was ultimately settled in favor of the plaintiff for an undisclosed amount.

Dr. Michota is director of academic affairs in the hospital medicine department at the Cleveland Clinic and medical editor of Hospitalist News. He reported having no relevant financial conflicts.