- Question
- Does tranexamic acid reduce perioperative bleeding in patients undergoing noncardiac surgery without increasing cardiovascular complications?
- Design
- Randomized, double-blind, placebo-controlled trial with a partial factorial design, enrolling 9535 patients undergoing noncardiac surgery. This report covers the tranexamic acid versus placebo comparison; the blood pressure management strategy comparison is reported separately.
- Population
- Adult patients undergoing noncardiac surgery who were at risk of bleeding and of perioperative cardiovascular complications.
- Intervention
- Tranexamic acid as a 1 g intravenous bolus at the start and again at the end of surgery.
- Control
- Placebo (0.9% saline) given at the same time points.
- Primary outcome
- Efficacy: composite of life-threatening bleeding, major bleeding, or bleeding into a critical organ at 30 days. Safety: composite of myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism at 30 days, with a noninferiority margin of 1.125 for the upper boundary of the HR.
- Results
- The composite bleeding outcome occurred in 433 of 4757 patients (9.1%) with tranexamic acid and 561 of 4778 (11.7%) with placebo (HR 0.76; 95% CI 0.67 to 0.87; absolute difference -2.6 percentage points; P<0.001 for superiority). The composite cardiovascular outcome occurred in 649 of 4581 patients (14.2%) and 639 of 4601 (13.9%), respectively (HR 1.02; 95% CI 0.92 to 1.14).
- Safety
- The composite cardiovascular safety outcome was similar between groups, but the upper boundary of the one-sided 97.5% CI was 1.14 (P = 0.04 for noninferiority), so noninferiority was not established.
- Conclusion
- Tranexamic acid significantly lowered the composite bleeding outcome compared with placebo in noncardiac surgery, although noninferiority for the composite cardiovascular safety outcome could not be demonstrated.
- Why it matters
- It provided large-scale evidence on an antifibrinolytic in noncardiac surgery, showing a clear bleeding benefit while leaving uncertainty about cardiovascular safety, which calls for individualizing its use according to patient risk.
Card generated automatically with AI from the abstract of the original publication and the trial registry; every figure was checked against those sources. It may contain errors: verify the data at the source before using it for clinical decisions.
Generated on October 14, 2026