Tranexamic Acid Policy Lowers Transfusion in Major Noncardiac Surgery

Key Takeaways

• Lower red-cell transfusion was observed with tranexamic acid than with placebo in the evaluable population.
• Venous thromboembolism rates were numerically similar, and the prespecified noninferiority comparison was met.
• The trial used a multicenter, double-blind, cluster-randomized, placebo-controlled hospital-policy design across 10 Canadian hospitals in patients undergoing noncardiac surgery who were at high risk for red-cell transfusion.

Among patients undergoing major noncardiac surgery, a hospital-wide intraoperative tranexamic acid policy was associated with red-cell transfusion in 7.4% of patients, compared with 9.8% with placebo. The randomized comparison came from a multicenter NEJM trial involving patients undergoing noncardiac surgery who were at high risk for red-cell transfusion at Canadian hospitals. The trial tested whether a hospital-wide policy could reduce red-cell transfusion without an observed loss of safety on the prespecified thromboembolism outcome.

This multicenter, double-blind, cluster-randomized, placebo-controlled trial enrolled patients undergoing noncardiac surgery who were at high risk for red-cell transfusion. Hospitals were randomly assigned at 4-week intervals to a hospital-wide policy of intraoperative tranexamic acid or placebo. The coprimary outcomes were red-cell transfusion during the index hospitalization and diagnosis of venous thromboembolism within 90 days. Among 8273 evaluable patients across 10 Canadian hospitals, oncologic surgery accounted for 60.5% of procedures, or 5002 cases, and mixed-effects models addressed the cluster-crossover design.

Red-cell transfusion during hospitalization occurred in 306 of 4156 patients, or 7.4%, in the tranexamic acid group and in 403 of 4117, or 9.8%, with placebo. The relative risk was 0.73 with a 95% confidence interval of 0.61 to 0.86, and the adjusted difference was -2.7 percentage points. The 95% confidence interval for the adjusted difference ranged from -4.2 to -1.4 percentage points. This coprimary outcome favored tranexamic acid for transfusion during the index hospitalization.

Venous thromboembolism within 90 days occurred in 86 of 4128 patients, or 2.1%, with tranexamic acid and in 85 of 4052, or 2.1%, with placebo. The relative risk was 0.96 with a 95% confidence interval of 0.65 to 1.38, and the adjusted difference was -0.1 percentage points. The 95% confidence interval for the adjusted difference ranged from -0.9 to 0.7 percentage points, and the prespecified noninferiority margin was defined as an upper boundary of 1.46 for the 95% confidence interval of the relative risk. The 90-day thromboembolism result met the trial's prespecified noninferiority threshold.

The study was published online on June 10, 2026, and appeared in the June 25, 2026, issue of the New England Journal of Medicine.