Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial
This RCT in adults with severe GI bleeding (n=12,009) found no difference between tranexamic acid and placebo in death due to bleeding within 5 days (4% v 4%; RR 0.99; 95% CI 0.82-1.18) with a higher risk of VTE events (1.85; 95% CI 1.15-2.98) and seizures (1.73; 1.03-2.93).
Source:
The Lancet
SPS commentary:
A related comment states that based on these findings, the routine use of tranexamic acid in adults with severe GI bleeding should be halted, as it is unlikely to be of benefit and there can be adverse events associated with use of the higher dose (1g loading, followed by 3g over 24 hours). Of note the adverse events were analysed as single outcomes, increasing the risk of type 1 and type 2 errors (overall over 40 outcomes were analysed); they suggest that an estimate of the total number of adverse effects would have been more precise and easier to interpret.