Effect of tranexamic acid on blood loss in pediatric cardiac surgery: A randomized trial

Purpose: The benefit of tranexamic acid (TXA) in pediatric cardiac surgery on postoperative bleeding has varied among studies. It is also unclear whether the effects of TXA differ between cyanotic patients and acyanotic patients. The aim of this study was to test the benefit of TXA in pediatric cardiac surgery in a well-balanced study population of cyanotic and acyanotic patients. Methods: A total of 160 pediatric patients undergoing cardiac surgery with cardiopulmonary bypass (81 cyanotic, 79 acyanotic) were included in this single-blinded, randomized trial at a tertiary care university-affiliated teaching hospital. Eighty-one children (41 cyanotic, 40 acyanotic) were randomly assigned to a TXA group, in which they received 50 mg/kg of TXA as a bolus followed by 15 mg/kg/h infusion and another 50 mg/kg into the bypass circuit. The other 79 patients were randomly assigned to a placebo group. The primary end point was the amount of 24-h blood loss. Results: The amount of 24-h blood loss was significantly less in the TXA group than in the placebo group [mean (95% confidence interval): 18.6 (15.8-21.4) vs. 23.5 (19.4-27.5) ml/kg, respectively; mean difference -4.9 (-9.7 to -0.01) ml/kg; p = 0.049]. This effect of TXA was already significant at 6 h [9.5 (7.5-11.5) vs. 13.2 (10.6-15.9) ml/kg, respectively; mean difference -3.47 (-7.0 to -0.4) ml/kg; p = 0.027]. However, there was no significant difference in the amount of blood transfusion between the groups. There was also no statistical difference in the effect of TXA in each cyanotic and acyanotic subgroup. Conclusion: TXA can reduce blood loss in pediatric cardiac surgery but not the transfusion requirement ( http://ClinicalTrials.gov number NCT00994994).