Background: TXA is an anti-fibrinolytic agent that decreases surgical bleeding and reduces death resulting from bleeding in trauma and postpartum hemorrhage. A 2012 Cochrane review suggested a reduction in mortality with use of TXA in patients with GI bleed, but previous trials were small with a high risk of bias.
Study design: Randomized, double-blind, placebo-controlled trial.
Setting: 164 hospitals in 15 countries.
Synopsis: A total of 12,009 patients presenting with suspected significant upper or lower GI bleeding were randomized to receive either high-dose TXA or placebo. Death resulting from bleeding within 5 days (primary outcome) was similar in the two groups (3.7% with TXA and 3.8% with placebo; relative risk, 0.99; 95% confidence interval, 0.82-1.18). All-cause mortality at 28 days was also similar (9.5% with TXA and 9.2% with placebo; RR, 1.03; 95% CI, 0.92-1.16).
There was an increase in venous thromboembolism (VTE; deep vein thrombosis or pulmonary embolism) in the TXA group versus the placebo group (0.8% with TXA and 0.4% with placebo; RR, 1.85; 95% CI, 1.15-2.98), as well as an increase in seizure events (0.6% with TXA and 0.4% with placebo; RR, 1.73; 95% CI, 1.03–2.93).
Bottom line: TXA did not reduce mortality risk in patients with upper or lower GI bleeding and should not be used in the routine management of GI bleed.
Citation: Roberts I et al. 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;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.
Dr. Chung is a hospitalist in the Division of Hospital Medicine, Mount Sinai Health System, New York.