HALT-IT - tranexamic acid for the treatment of gastrointestinal bleeding: Study protocol for a randomised controlled trial
Roberts I., Coats T., Edwards P., Gilmore I., Jairath V., Ker K., Manno D., Shakur H., Stanworth S., Veitch A.
© 2014 Roberts et al.; licensee BioMed Central Ltd.Background: Gastrointestinal bleeding is a common emergency that causes substantial mortality worldwide. Acute upper and lower gastrointestinal bleeding accounts for about 75,000 hospital admissions each year in the UK and causes the death of about 10% of these patients. Methods: HALT-IT is a pragmatic, randomised, double-blind, placebo-controlled trial which will determine the effect of tranexamic acid on mortality, morbidity (re-bleeding, non-fatal vascular events), blood transfusion, surgical intervention, and health status in patients with acute gastrointestinal bleeding. Eight thousand adult patients who fulfil the eligibility criteria will be randomised to receive tranexamic acid or placebo. Trial registration: Current Controlled Trials ISRCTN11225767 (registration date: 3 July 2012); Clinicaltrials.gov NCT01658124, (registration date: 26 July 2012).