High-dose tranexamic acid in acute gastrointestinal bleeding
HALT-IT trial design and results
Design
International randomised, double-blind, placebo-controlled trial
Treatment
High-dose 24-hour infusion of tranexamic acid
Control
Placebo
Population
12,009 patients with acute gastrointestinal bleeding
Follow-up
28 days
Primary endpoint
Death due to bleeding within 5 days
Result
Death due to bleeding within 5 days occurred in 222 of 5956 (4%) with tranexamic acid and 226 of 5981 (4%) with placebo — risk ratio 0.99 (95% CI 0.82 to 1.18). Arterial thromboembolic events were similar, 0.7% versus 0.8%. Venous thromboembolic events were higher with tranexamic acid, 48 of 5952 (0.8%) versus 26 of 5977 (0.4%) — risk ratio 1.85 (95% CI 1.15 to 2.98).
We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial.
The trial authors, in the published abstract
How it has aged
A clear, large negative that stopped extrapolation from trauma and postpartum haemorrhage, where tranexamic acid does work (WOMAN). The authors' recommendation is unusually direct, and correspondingly easy to act on.
Publications
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
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. Lancet 2020 Jun 20;395(10241):1927-1936.