HALT-IT trial (Haemorrhage Alleviation with Tranexamic acid–Intestinal System), a large randomised placebo controlled trial among patients with acute gastrointestinal haemorrhage of the effects of tranexamic acid on death and transfusion requirement
A cheap, widely used drug that prevents bleeding deaths in trauma patients is being tested in a large international trial to see if it can do the same for people with severe gastrointestinal bleeding. Gastrointestinal bleeding kills tens of thousands of people worldwide each year. The drug, tranexamic acid (TXA), is already known to reduce death from bleeding in trauma, but its effect on GI bleeding has not been tested in a modern, high-quality trial. Earlier studies were small and conducted decades ago, before the routine use of endoscopy and acid-suppressing drugs, so doctors have little reliable evidence to guide treatment. If TXA works for GI bleeding, it could offer a simple, low-cost way to reduce deaths from a common emergency. The drug is already on hospital shelves and costs little, so the main barrier is proving it works. This trial will provide the definitive answer. If positive, it could change standard care worldwide—saving lives without requiring new equipment, training, or infrastructure. If negative, it will prevent the waste of a drug that does not help. Either way, the result will settle a long-standing uncertainty in emergency medicine.
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The HALT-IT trial is a randomised double-blind placebo controlled trial to evaluate the safety and cost-effectiveness of giving tranexamic acid (TXA) to adults with acute severe gastrointestinal (GI) bleeding. TXA is widely used to treat menorrhagia and is used in surgery to reduce bleeding. In 2010, the CRASH-2 trial showed that TXA reduces mortality in bleeding trauma patients. TXA reduces death due to bleeding (RR=0.85, 95% CI 0.76 to 0.96; p=0.008) and all cause mortality (RR=0.91, 95% CI 0.85 to 0.97; p=0.004), with no apparent increase in vascular occlusive events. TXA could also reduce mortality in GI bleeding. When combined, previous trials of TXA in GI bleeding show a mortality reduction (RR=0.67, 95% CI 0.47 to 0.95; p=0.02), although the quality of the trials is poor. Most previous trials were conducted in the 1970s and 80s before the use of endoscopy and proton pump inhibitors (PPI). The poor quality of the evidence and concerns about its applicability probably explain why few patients with GI bleeding are treated with TXA. The HALT-IT trial will randomly allocate 8,000 patients with GI bleeding to receive a loading dose of 1 g of TXA infused over 10 minutes, followed by an intravenous infusion of 3 g over 24 hours, or matching placebo. TXA or placebo will be administered in addition to the normal medical or surgical treatment for acute severe GI bleeding. We will assess the effect of TXA on all-cause mortality, side effects and health-related quality-of-life. The trial design and outcomes were decided upon following discussion with user groups. The trial is coordinated by a CTU with experience in clinical trials in emergency situations. We work with an established international network of doctors who have a proven track record of recruitment to emergency care trials. To ensure that the results of the trial apply to patients in the NHS, there will be a strong focus on UK recruitment which will contribute about 2,000 patients. The clinical leadership provided by the applicants Professor Ian Gilmore (president of British Society of Gastroenterology) and Dr Andrew Veitch (Chair of the UK Endoscopy Research Network) and the support of the relevant CLRN will help with this.
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