Tranexamic acid (TXA) for prophylaxis of major bleeding is effective in general surgery without increasing vascular risk compared to placebo. This is the conclusion of the international phase 3 randomized controlled trial called Poise-3. The results are published in the Jama Surgery.
The study included 9,535 patients over 45 years old, undergoing non-cardiac surgery with at least one night of post-operative hospitalization and with an increased cardiovascular risk, in order to evaluate the effectiveness but also the safety of the TXA versus placebo. The authors performed several subanalyses evaluating general and nongeneral surgeries.
Tranexamic acid is already used in practice to prevent bleeding during cesarean sections, cardiac surgeries and even in trauma. Apart from these situations, data was lacking. So, for the authors, “Poise-3 provides the optimal estimate of the effect of tranexamic acid in non-cardiac surgery, including general surgery.”
With tranexamic acid, 8% bleeding compared to 10.5% with placebo
In the sub-analysis concerning general surgeries, 3,260 patients (average age 68.6 years and 53.4% men) were randomized to receive at the start and end of surgery, i.e. 1 g of TXA bolus intravenously (n = 1,635), or placebo (n = 1,625). For the main endpoint (occurrence of serious bleeding or major hemorrhage or hemorrhage in a major organ), the authors found 8% of events in the TXA group compared to 10.5% in the group placebo (RR = 0.74).
Looking at general surgery subtypes, the authors found a significantly greater reduction in the risk of bleeding with TXA in hepatopancreaticobiliary surgeries (HR = 0.55) and colorectal surgeries (HR = 0.67). Concerning safety, the authors did not find an increased risk of myocardial damage after non-cardiac surgery, non-hemorrhagic stroke, peripheral arterial thrombosis or symptomatic deep vein thrombosis at 30 days in the TXA group (11.9 versus 12.5% events in the placebo group, HR = 0.95). Finally, among the patients in this subanalysis, 40% of each group (TXA or placebo) had active cancer. The authors found similar effectiveness of TXA, regardless of the cancer status.
In the other sub-analyses of the Poise-3 study, the authors also found efficacy and safety of TXA for prophylaxis in non-general surgeries (n = 6,208).
