6/28/23, 11:01 PM HALT-IT Pathway Feedback Search Clinical Topics Home Studies HALT IT HALT IT Disease Disease Disease Lower gastrointestinal bleeding Non-variceal upper gastrointesti Varicea Trial question What is the effect of a high-dose 24-hour infusion of tranexamic acid in patients with acute gastrointestinal bleeding? Study design Multi-center Double blinded RCT Population Characteristics of study participants 36.0% female N = 12009 64.0% male 12009 patients (4266 female, 7743 male) Inclusion criteria: adult patients with significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding Key exclusion criteria: the responsible clinician's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular patient with upper or lower gastrointestinal bleeding Interventions N=5994 tranexamic acid (slow intravenous infusion of a 1 g loading dose followed by a maintenance dose of 3 g for 24 hours) N=6015 placebo (matching intravenous infusion of sodium chloride 0.9%) Primary outcome Rate of death due to bleeding within 5 days 3.8 3.8 % 3.7 https://web.pathway.md/studies/recXvWfP4jGec0hyO 1/2 6/28/23, 11:01 PM HALT-IT Pathway 3 2.8 % 1.9 % 0.9 % No significant difference 0.0 % Tranexamic acid Placebo No significant difference in the rate of death due to bleeding within 5 days (3.7% vs. 3.8%; RR 0.99, 99% CI 0.82 to 1.18) Secondary outcomes No significant difference in arterial thromboembolic events (myocardial infarction or stroke) (0.7% vs. 0.8%; RR 0.92, 95% CI 0.6 to 1.39) Borderline significant increase in venous thromboembolic events (deep vein thrombosis or PE) (0.8% vs. 0.4%; RR 1.85, 95% CI 1.15 to 2.98) No significant difference in the rate of death from all-causes within 28 days (9.5% vs. 9.2%; RR 1.03, 95% CI 0.92 to 1.16) Safety outcomes No significant differences in renal failure, liver failure, respiratory failure, cardiac events, sepsis, pneumonia, days in ICU, and Katz score. Significant differences in seizure (0.6% vs. 0.4%), deep vein thrombosis (0.4% vs. 0.2%), pulmonary thrombosis (0.5% vs.s 0.3%). Conclusion In adult patients with significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding, tranexamic acid was not superior to placebo with respect to the rate of death due to bleeding within 5 days. Reference HALT-IT Trial Collaborators. 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. Open reference URL https://web.pathway.md/studies/recXvWfP4jGec0hyO 2/2