Research Summary

Tranexamic Acid Reduces Bleeding Without Increasing Cardiovascular Risk in General Surgery

Kate Young

A new analysis of the POISE-3 trial has demonstrated that tranexamic acid (TXA) significantly reduces perioperative bleeding in patients who undergo general surgery without increasing the risk of major cardiovascular complications. The findings, based on a subgroup analysis of 3260 patients who underwent general surgery from the larger international, multicenter randomized clinical trial, provide strong evidence supporting TXA’s use in surgical practice.

“Perioperative bleeding is common in general surgery,” the study authors wrote. “The POISE-3 (Perioperative Ischemic Evaluation-3) trial demonstrated efficacy of prophylactic tranexamic acid compared with placebo in preventing major bleeding without increasing vascular outcomes in noncardiac surgery.”

The POISE-3 trial, designed to evaluate the efficacy and safety of prophylactic TXA in preventing major bleeding in noncardiac surgery, included patients aged 45 years or older who were at increased cardiovascular risk and required at least an overnight hospital stay following surgery. Of 26,581 eligible patients, 9535 were randomized to receive either a 1-gram intravenous bolus of TXA or a placebo at the start and end of surgery. Researchers assessed outcomes related to major bleeding and vascular complications at 30 days post-surgery.

In the general surgery cohort, the use of TXA led to a statistically significant reduction in major perioperative bleeding. The primary efficacy outcome—defined as a composite of life-threatening bleeding, major bleeding, or bleeding into a critical organ—occurred in 8.0% of patients receiving TXA compared with 10.5% in the placebo group, reflecting a 26% relative risk reduction. The study found no increased risk of cardiovascular complications, with 11.9% of patients treated with TXA experiencing the primary safety outcome compared with 12.5% in the placebo group.

Patients undergoing hepatopancreaticobiliary surgery saw the most significant reduction in bleeding risk, with a hazard ratio of 0.55, while those undergoing colorectal surgery also benefited, with a hazard ratio of 0.67. The protective effect of TXA appeared consistent across different general surgery subtypes.

“In this study, TXA significantly reduced the risk of perioperative bleeding without increasing cardiovascular risk in patients undergoing general surgery procedures,” the authors concluded.

Reference:
Park LJ, Marcucci M, Ofori SN, et al. Safety and efficacy of tranexamic acid in general surgery. JAMA Surg. 2025;160(3):267-274. doi:10.1001/jamasurg.2024.6048.