HALT-IT Trial Results and News

HALT-IT Trial Results and News

After 6 years of international collaboration, we are delighted to be sharing with you the HALT-IT trial results. This trial emphasises why clinical trials that do not show benefit are equally important to those that do.

Understanding that TXA does not improve outcomes in GI bleeding patients but instead may increase side effects means that future patient care will have updated protocols solely through these researched outcomes.


The HALT-IT trial investigated the effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT) and was an international randomised, double-blind, placebo-controlled trial

The HALT-IT trial is assessing whether early administration of tranexamic acid in people with acute gastrointestinal bleeding can reduce their risk of dying in the hospital. The trial is also measuring the effects of the treatment on re-bleeding, non-fatal vascular events, blood transfusion, surgical intervention and general health status.

Gastrointestinal bleeding is a common emergency with a 10-15% death rate. An effective treatment could save thousands of lives worldwide, In the CRASH-2 trial, we showed that, if given within 1 hour, tranexamic acid reduces mortality in bleeding trauma patients. Specifically, tranexamic acid reduces the risk of bleeding to death by about one third, with no increase in side effects. If tranexamic acid was shown to have similar effects in gastrointestinal bleeding, this would be a major advance.

The HALT-IT trial began recruitment on 4 July 2013 and is aiming to recruit 12,000 patients from hospitals worldwide by 31 May 2019.

However, The HALT-IT trial results found that tranexamic acid does not reduce deaths from stomach bleeding but increases the risk of thromboembolic events (deep vein thrombosis or pulmonary embolism). There were also more seizures with tranexamic acid. Re-bleeding was similar in both groups.

Although it is often assumed that a treatment that works in one bleeding situation (such as traumatic bleeding or postpartum haemorrhage) will probably work in another, these results highlight the need for clinical trials that target specific causes of bleeding. Stomach bleeding may respond differently, and particularly patients with underlying liver disease may be more prone to side effects from unwanted clotting.

On the basis of these results, TXA should not be used for the treatment of GI bleeding outside the context of a randomised trial.

To read HALT-IT Trial publication on The Lancet CLICK HERE 


So, what do the HALT-IT trial results mean for clinical practice moving forward?

This trial emphasises why clinical trials that do not show benefit are equally important to those that do.

Understanding that TXA does not improve outcomes in GI bleeding patients but instead may increase side effects means that future patient care will have updated protocols solely through these researched outcomes.

Clinical Trial Unit’s Co-Director, Professor Ian Roberts has written an opinion piece regarding HALT-IT trial.

Alternatively, take a listen to The Resus Room’s podcast, HALT-IT trial episode featuring an interview with Professor Roberts.

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