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Monday, June 27, 2022

HALT-IT

emDocs - June 27, 2022 - By Brannon Inman / Reviewed by: Alex Koyfman
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 randomized, double-blind, placebo-controlled trial
Take away: This is a negative trial.
  • Included patients with upper and lower GI bleeds as one group, which is not how we typically classify these patients. The majority of patients had variceal bleed, accounting for 75% of deaths. Less than 10% of included patients were on anticoagulants.
  • Only 69% of patients required transfusion, and 87% had SBP > 90 mm Hg with 30% having a HR > 107.
  • Time from onset to randomization < 3 hours was present in 16% of patients. Most patients received TXA over 8 hours from time of bleeding onset.
  • Primary outcome changed from all-cause mortality to GI bleeding related mortality in 5 days. Reportedly this decision was made blind to the accumulating data. Changing a primary outcome from a patient-centered outcome to a disease-centered outcome is odd. Our patients do not care what they die from, nor do their families. With the used primary outcome, patients could have been dying from TXA complications, and this would not have been captured (albeit this is unlikely).
  • Very few trials have shown harm associated with TXA. This trial showed a statically significant risk of VTE and seizures.
My take
  • This is a well-constructed, multicenter RCT comparing TXA versus placebo for patients with acute GI bleeding. Based on the results from this RCT, TXA does not reduce death from GI bleeding and may increase risk of VTE and seizure.
  • I won’t be using TXA for GI bleed patients in my clinical practice.