Questions and Methods: This was an international, randomized, double-blind, placebo-controlled trial with the objective to quantify the effect of TXA on death due to bleeding in acute GI bleeds.
Findings: Death due to bleeding at 5 days was similar between both groups (3.7% vs. 3.8% for TXA vs. placebo, respectively, RR 0.99) with a small increased risk of VTE in the TXA group (0.8% for TXA versus 0.4% in placebo).
Limitations: Although the biggest flaw in this study was the change in the primary outcome from all cause-mortality to death due to bleeding, this did not significantly change the study results.
Interpretation: Overall this is a well-designed RCT. Based on this trial’s results, we should not be routinely using TXA for patients with acute GI bleeding.