Prophylactic Tranexamic Acid May Reduce Perioperative Bleeding Risk in General Surgery

January 27, 2025

Prophylactic tranexamic acid (TXA) reduced the risk of perioperative bleeding during general surgery without compromising vascular health, according to a subgroup analysis of data from the Perioperative Ischemic Evaluation-3 (POISE-3) trial published recently in JAMA Surgery.

In the analysis, researchers found that 8% of patients undergoing general surgery who received TXA experienced the composite efficacy primary endpoint of life-threatening bleeding, major bleeding and critical organ bleeding at 30 days compared with 10.5% for those who received placebo (P = .01). In addition, 11.9% and 12.5% of general surgery patients receiving TXA and placebo respectively experienced the composite efficacy primary endpoint of myocardial injury after noncardiac surgery, nonhemorrhagic stroke, peripheral arterial thrombosis and symptomatic venous thromboembolism (VTE).

“The POISE-3 trial provides the optimal estimate of effect for TXA in noncardiac surgery, including general surgery,” reducing “the risk of composite bleeding without increasing the risk of a composite cardiovascular risk outcome,” the authors wrote.

TXA use has already been shown to reduce bleeding in specific situations, including post-caesarian hemorrhage, cardiac surgery, major orthopedic and spine surgical procedures, and trauma. However, the drug’s mechanism of action — antifibrinolysis — has been associated with an increased risk for thromboembolic complications.

This sub analysis of the POISE-3 trial included 3, 260 general surgery patients, of whom 1,635 received perioperative TXA. The mean age was 68.6 years; more patients were male (53.4%). Slightly more than 40% (40.8%) of patients had active cancer. The overall study population included 6,208 patients who underwent nongeneral surgery procedures —3,093 received TXA and 3,115 received placebo — and 67 with an unknown category of noncardiac surgery.

The researchers noted that “there was no subgroup effect for TXA versus placebo in the general surgery subpopulation when compared with the nongeneral surgery subpopulation.” In addition, the effects of TXA compared with placebo in terms of primary efficacy and safety endpoints did not vary by cancer status within the general surgery group.

The authors noted that the study is limited in that it is that this was a subgroup analysis and, therefore, not powered for the subgroups and subcategories explored.

In considering the varying effectiveness of TXA on bleeding based on published trials in a range of bleeding situations (e.g., non-penetrating trauma, brisk profuse bleeding, significant upper and lower gastrointestinal bleeding, etc.), the researchers observed that “these contextual nuances may introduce variability that obscures TXA effectiveness, underscoring the importance of large-scale studies. Although TXA likely cannot address all forms of bleeding, our work demonstrates it is able to reduce the risk of clinically important bleeding in general surgery contexts.”