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
62.0% male
N = 3031
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/hr maintenance dose, and 2 mg/kg prime).
N=1506 low-dose tranexamic acid regimen (10 mg/kg bolus, 2 mg/kg/hr maintenance dose, and 1 mg/kg prime).
Primary outcome
Allogeneic red blood cell transfusion
21.8%
26%
26.0 %
19.5 %
13.0 %
6.5 %
0.0 %
High-dose tranexamic acid
regimen
Low-dose tranexamic acid
regimen
Significant
decrease ▼
NNT = 23
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 duration of mechanical ventilation (15 hours vs. 14.5 hours).
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 were 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.
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