The HALT-IT Trial(1) is an important trial and one we should know well. It looks at the use of Tranexamic Acid (TXA) in gastrointestinal bleeding. Prior to this trial a Cochrane systematic review and meta analysis reported a significant reduction in mortality with TXA. This trial changed practice. (10 minute read)
What They Did
This was a randomised, double blind placebo-controlled trial in 154 hospitals and 15 countries.
N=12009
Patients received a loading dose of 1g of TXA or placebo (sodium chloride 0,9%) in 100mL of sodium chloride 0.9%, infused over 10 minutes. Then 125 mg/hr of TXA or placebo was transfused over 24 hours.
Primary Outcome: death due to bleeding within 5 days.
Secondary Outcomes included:
- death due to bleeding within 24 hours and within 28 days
- rebleeding within 24 hours, 5 days and 28 days.
- blood product transfusion
- thromboembolic events (DVT, PE, stroke, myocardial infarction)
- seizures
- days in ICU
- functional status
The study included adult patients of all age groups and also included:
- patients with signs of shock
- patients with hypotension and tachycardia
- patients with high Rockall scores
- patients taking anticoagulants
- patients with significant comorbidities including cardiovascular, respiratory, renal, liver and malignancy.
What They Found
There was no difference between the two groups in terms of death due to bleeding within 5 days: TXA (3.7%) vs placebo (3.8%)
There was no difference in any of:
- death due to bleeding within 24 hours
- death due to bleeding within 28 days
- death from all causes at 28 days
There was an increased risk of venous thromboembolic events in the TXA group and these were higher in patients with suspected variceal bleeding or liver disease. There was also a small increased risk of seizures in the treatment group.
My Take on this
This is the largest study to date and a randomised double blind placebo-controlled trial. It found that TXA gives no benefit in survival at 5 days for patients with a significant gastrointestinal bleed (even if on anticoagulants) and results in a slight increase in seizures and venous thromboembolic events.
We know that in trauma and in postpartum haemorrhage TXA reduces mortality if given early. In gastrointestinal bleeding, the exact onset time may be more difficult to ascertain. We now know that TXA has no role in gastrointestinal bleeding. This is practice defining research.
References
The HALT-IT Trial Collaborators. Effects of a high-dose 24-h infusion of trqnexamoc acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. The Lancet. 2020;395; 1927-1936.
