HALT-IT
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
64.0% male
N = 12009
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
3.7%
3.8%
3.8 %
2.8 %
1.9 %
0.9 %
0.0 %
Tranexamic
acid
Placebo
No significant
difference ↔
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 (MI or stroke) (0.7% vs. 0.8%; RR 0.92, 95% CI 0.6 to 1.39).
Significant increase in venous thromboembolic events (DVT 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%), DVT (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.
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