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Original paper
2020LancetGastroenterology/Hepatology

HALT-IT

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

RCTGI bleed

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Overview

High-dose 24-hour tranexamic acid did not reduce death from GI bleeding and increased venous thromboembolic events.

Clinical takeaway

HALT-IT removed GI bleeding as an indication for TXA outside a trial: the same drug that helps trauma bleeding did not reduce GI bleeding deaths at this dose.

Key result

Death due to bleeding within 5 days was 4% with TXA vs 4% with placebo (RR 0.99).

Practice impact

Do not give tranexamic acid for gastrointestinal bleeding as routine care.

Evidence

Study design

International, multicentre, randomised, placebo-controlled trial.

Enrollment

12,009

Follow-up

Death due to bleeding within 5 days of randomisation.

Geography

15 countries

Clinical question

Does a high-dose 24-hour infusion of tranexamic acid reduce death due to bleeding in acute gastrointestinal bleeding?

Population

  • Adults with significant upper or lower gastrointestinal bleeding, enrolled when the clinician was uncertain whether to use tranexamic acid.

Intervention

Tranexamic acid 1 g over 10 minutes, then 3 g over 24 hours at 125 mg/h.

Comparator

Matching placebo (0.9% sodium chloride).

Primary outcome

Death due to bleeding within 5 days of randomisation.

High-dose tranexamic acid did not reduce death from gastrointestinal bleeding compared with placebo.

Risk ratio / 0.99 / 95% CI 0.82-1.18

Key results

  • Death due to bleeding within 5 days was 4% with TXA vs 4% with placebo; RR 0.99 (95% CI 0.82-1.18).
  • Arterial thromboembolic events (myocardial infarction or stroke) were similar between groups.
  • Venous thromboembolic events were higher with TXA (RR 1.85, 95% CI 1.15-2.98).

Harms

  • Arterial thromboembolic events were similar (0.7% vs 0.8%).
  • Venous thromboembolic events (DVT or PE) were higher with TXA (0.8% vs 0.4%; RR 1.85, 95% CI 1.15-2.98).

Clinical Use

Practice impact

  • Do not give tranexamic acid for gastrointestinal bleeding as routine care.

Applicability

  • Most applicable to adults with significant upper or lower GI bleeding when the clinician is uncertain about using TXA.

Limitations

  • The regimen was a 1 g load plus a 24-hour 3 g infusion, not a short trauma-style course.
  • Enrollment required clinician uncertainty about using TXA.
  • Upper and lower gastrointestinal bleeding were studied together.

Common misinterpretations

  • Trauma TXA evidence does not transfer to gastrointestinal bleeding.
  • Arterial events were similar; the safety signal here was venous thromboembolism.

Related evidence

CRASH-2 - Contrasting ResultVillanueva UGIB transfusion trial - Same DiseaseLau UGIB endoscopy timing trial - Same DiseaseWOMAN - Same Drug Class

Citation

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;395(10241):1927-1936. doi:10.1016/S0140-6736(20)30848-5

We found that tranexamic acid did not reduce death from gastrointestinal bleeding.