Haemorrhage alleviation with tranexamic acid [HALT-IT] [Version 1.0]
Research type
Research Study
Full title
Tranexamic acid for the treatment of gastrointestinal haemorrhage: an international randomised, double blind placebo controlled trial
IRAS ID
111368
Contact name
Ian Roberts
Sponsor organisation
London School Of Hygiene and Tropical Medicine
Eudract number
2012-003192-19
ISRCTN Number
ISRCTN11225767
Clinicaltrials.gov Identifier
Research summary
More than 65,000 people each year are admitted to British hospitals because of acute gastrointestinal (GI) bleeding (bleeding from the gut). About 10% of them die. GI bleeding is usually caused by stomach ulcers. Liver damage from alcohol is another cause and with people drinking excessively in the UK, this is a growing problem. An effective and affordable treatment for GI bleeding could save many lives.
HALT-IT is an international, randomised trial in patients with significant GI bleeding which will look to see if giving a drug called tranexamic acid leads to better outcomes in patients with GI bleeding, in particular reducing deaths. Tranexamic acid helps blood to clot, thus decreasing bleeding. A trial in bleeding accident victims found that tranexamic acid reduces the chances of bleeding to death without any increase in side effects. But not enough research has been done to show if the tranexamic acid safely reduces GI bleeding.
Adult patients with significant GI bleeding are eligible for the trial. Patients for whom the doctor is certain that the drug should be given or where it is certain the drug should not be given should not be included. We plan to study 8,000 patients worldwide with significant GI bleeding. We will give half of them tranexamic acid and the other half a placebo in addition to all other treatments needed. To make sure that the two groups are similar apart from tranexamic acid, we will decide who gets tranexamic acid and who gets placebo randomly. Patients will receive the trial treatment through a drip for 24 hours. Patients will be followed-up for a maximum of 28 days in hospital. Patient status (death, hospital readmission) will also assessed at 12 months.
The trial is funded by the National Institute of Health Research.REC name
East of England - Essex Research Ethics Committee
REC reference
13/EE/0038
Date of REC Opinion
22 Feb 2013
REC opinion
Favourable Opinion