Halt-it

Haemorrhage alleviation with tranexamic acid – Intestinal system (Halt-it)

Date opened:
Type:
International randomised, double blind placebo trail
Size:
Multi-centre
Current status: 
Open
Recruitment to date: 107
Lead researcher (Birmingham): Dr Elaine Hardy

Overview

Acute gastrointestinal (GI) bleeding is a common emergency and a significant cause of mortality and morbidity worldwide.

It is associated with poor patient outcomes and frequent re-admissions to hospital.

Acute upper GI bleeding accounts for approximately 60,000 hospital admissions each year in the United Kingdom, with about 10% of cases proving fatal. Lower GI bleeding accounts for about 15,000 admissions annually, with about 15% resulting in death.

GI bleeding is also common in low and middle income countries, where patients are usually young and poor.

Who is eligible

The study will recruit patients aged 18 and over who have a suspected upper or lower GI bleed and no clear indication or contraindication for TXA.

The trial

The Halt-It study – an international randomised, double blind placebo trail – aims to provide reliable evidence about the effect of tranexamic acid (TXA) on mortality and disability in patients with GI bleeding.

TXA is commonly administered to surgical patients to reduce bleeding and the need for blood transfusions but we do not know whether giving it on top of all the other emergency treatments will help or not.

Half of the patients on the study will get TXA with the other half receiving a placebo. The choice of what is given (active treatment or placebo) is made randomly, with an equal chance of receiving either one.

Neither the patient nor the doctor in charge of their care will be told which treatment has been given.

Measuring success

PRIMARY OUTCOME:

The primary outcome is death in hospital within 28 days of randomisation (cause-specific mortality will also be recorded).

SECONDARY OUTCOMES:
a) Re-bleeding
b) Need for surgery or radiological intervention
c) Blood product transfusion
d) Thromboembolic events (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction)
e) Other complications (significant cardiac event, sepsis, pneumonia, respiratory failure, renal failure, liver failure, seizures)
f) Patient’s self care capacity using the Katz Index of Independence in Activities of Daily Living
g) Days spent in intensive care unit or high dependency unit
h) Patient status (death, hospital readmission) at 12 months