OUTCOME MEASURES AND DATA ANALYSIS
Primary outcome measures were transfusion requirements and estimated blood loss. Secondary outcome measures were postoperative decrease in hemoglobin, length of stay, and postoperative drain output. Demographic and operative data were compared between groups to ensure that there were no statistically significant differences in blood loss and transfusion requirements. All data were recorded in a password encrypted file and subsequently transferred to the REDCap system (Research Electronic Data Capture, Vanderbilt University).
STATISTICAL ANALYSIS
A priori sample size calculation was performed on the basis of a prior study 28, which evaluated surgical blood loss reduction utilizing a bipolar sealer. This study suggested a sample size of 20 per group to detect the minimal clinically important difference of 1.5 (standard deviation (SD) = 1.5, α = 0.05, β = 0.20). Additionally, a general estimate for detecting a 1-unit change on an ordinal scale of 136 (SD = 1.0, α = 0.05, β = 0.20) resulted in the same number. We conservatively chose to include at least 24 patients in each study arm in the event of greater true variance. The Wilcoxon rank-sum test was used for comparison of continuous data between groups. Differences between means were analyzed using 2-sided t tests. Comparison of categorical data was performed using Pearson’s chi-square or Fisher’s exact probability test as indicated. Ordinal ranking scores were compared using the Mantel-Haenszel test.
RESULTS
There were no statistically significant differences between groups with respect to sex, age, body mass index, or preoperative hemoglobin level (Table 1). Two patients in the TXA group and 10 patients in the control group were transfused (P = .02). In the TXA + bipolar sealer group, 1 patient was transfused (P = .02). A comparison of the transfusion rate between the TXA group and the TXA + bipolar sealer group yielded no significant difference (P = .99). The estimated blood loss was 310.3 mL ± 182.5 mL in the TXA group (P = .004), 292.9 mL ± 130.8 mL in the TXA + bipolar sealer group (P = .003), and 404.9 mL ± 201.2 mL in the control group (P = .71) (Table 2).
Table 2. Patient-Related Outcomes
TXA Only (N = 63) | TXA + Bipolar Sealer (n = 49) | Control (n = 61) | P-value (TXA vs Control) | P-value (TXA + Sealer vs Control) | P-value (TXA + Sealer vs TXA) | |
Patients Transfuseda | 2 (3.2%) | 1 (2.0%) | 10 (16.4%) | .02 | .02 | .99 |
Hemoglobin Drop (g/dL)b = preoperative Hb-lowest Hb | 3.5 ± 0.8 (1.8-6.3) | 3.5 ± 1.1 (1.7-6.0) | 4.3 ± 1.2 (2.0-7.5) | <.001 | <.001 | .60 |
Total Drain Output (mL)b | 326.3 ± 197.5 (15-1050) | 309.8 ± 196.3 (20-920) | 473.6 ± 199.7 (90-960) | <.001 | <.001 | .58 |
Calculated Blood Loss (mL)b = 1000 x total Hb loss/preoperative Hb | 1217.8 ± 335.8 (573.0-2514.4) | 1289.5 ± 382.4 (536.1-2418.2) | 1514.7 ± 467.9 (789.4-3451.1) | <.001 | .005 | .43 |
Estimated Blood Loss (mL)b | 310.3 ± 182.5 (100-1400) | 292.9 ± 130.8 (75-600) | 404.9 ± 201.2 (150-1000) | .004 | .003 | .71 |
Length of Stay (d)a | 2.2 ± 0.6 (1-4) | 2.2 ± 0.9 (1-5) | 2.6 ± 0.8 (1-5) | .004 | .03 | .78 |
aResult values are expressed as mean ± standard deviation (range). bResult values are expressed as number of cases (percentage of column header population).
Abbreviation: TXA, tranexamic acid.
The total drain output was 326.3 mL ± 197.5 mL in the TXA group (P < .001 for comparison with the control group), 309.8 mL ± 196.3 mL in the TXA + bipolar sealer group (P < .001 for comparison with the control group), and 473.6 mL ± 199.7 mL in the control group (P = .58). The decrease in hemoglobin was 3.5 g/dL ± 0.8 g/dL in the TXA group (P < .001), 3.5 g/dL ± 1.1 g/dL in the TXA + bipolar sealer group (P < .001), and 4.3 g/dL ± 1.2 g/dL in the control group (Table 2). The length of stay was 2.2 ± 0.6 days for the TXA group (P = .004) and 2.2 ± 0.9 days (P = .03) for the TXA + bipolar sealer group, and 2.6 ± 0.8 days in the control group (P = .78) (Table 2).
DISCUSSION
This study shows that the use of TXA alone provides a significant decrease in transfusion rates and estimated blood loss, a benefit which was not further increased with the addition of a bipolar sealer (Table 2). Many studies have demonstrated that TXA reduces blood loss and transfusion rates in patients undergoing THA and TKA.29 However, TXA’s acceptance as a more readily used hemostatic medication has been hindered by the theoretically increased risk of thromboembolism in susceptible, high-risk patients.32-35 In a 2012 meta-analysis conducted by Yang and colleagues,36 the use of TXA led to significantly less blood loss per patient and fewer transfusions without leading to an increased risk of thromboembolic events.
Continue to: Similarly, the bipolar sealer...