6/28/23, 11:44 PM OPTIMAL Pathway Feedback Search Clinical Topics Home Studies OPTIMAL OPTIMAL Trial question Is high-dose infusion of tranexamic acid superior to low-dose infusion in patients undergoing cardiac surgery with cardiopulmonary bypass? Study design Multi-center Double blinded RCT Population Characteristics of study participants 38.0% female N = 3031 62.0% male 3031 patients (1155 female, 1876 male) Inclusion criteria: adult patients undergoing cardiac surgery with cardiopulmonary bypass Key exclusion criteria: acquired defective chromatic vision; active intravascular coagulation; history of thrombophilia; previous convulsion or seizure Interventions N=1525 high-dose tranexamic acid regimen (30 mg/kg bolus, 16 mg/kg/hour maintenance dose, and 2 mg/kg prime) N=1506 low-dose tranexamic acid regimen (10 mg/kg bolus, 2 mg/kg/hour maintenance dose, and 1 mg/kg prime) Primary outcome Allogeneic red blood cell transfusion 26.0 % 26 21.8 19.5 % 13.0 % Significant decrease https://web.pathway.md/studies/recLQsOmcXXYAaIAD 1/2 6/28/23, 11:44 PM OPTIMAL Pathway 6.5 % NNT = 24 0.0 % High-dose tranexamic acid regimen Low-dose tranexamic acid regimen Significant decrease in allogeneic RBC transfusion (21.8% vs. 26%; RR 0.84, 95% CI 0.27 to 1.41) Secondary outcomes Borderline significant decrease in postoperative chest tube output (490 mL vs. 530 mL; AD -25 mL, 95% CI -50 to 0) No significant difference in reoperation for bleeding (1% vs. 1.4%; RR 0.75, 95% CI 0.39 to 1.43) Safety outcomes Significant differences in postoperative seizure, thrombotic events, kidney dysfunction, or death at day 30 (17.6% vs. 16.8%). Conclusion In adult patients undergoing cardiac surgery with cardiopulmonary bypass, high-dose tranexamic acid regimen was superior to low-dose tranexamic acid regimen with respect to allogeneic RBC transfusion. Reference Jia Shi, Chenghui Zhou, Wei Pan et al. Effect of High- vs Low-Dose Tranexamic Acid Infusion on Need for Red Blood Cell Transfusion and Adverse Events in Patients Undergoing Cardiac Surgery: The OPTIMAL Randomized Clinical Trial. JAMA. 2022 Jul 26;328(4):336-347. Open reference URL https://web.pathway.md/studies/recLQsOmcXXYAaIAD 2/2