Condition category
Digestive System
Date applied
26/06/2012
Date assigned
03/07/2012
Last edited
17/12/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Severe bleeding in the digestive system is a common symptom of many diseases. Each year, about 50,000 people end up in British hospitals because of this problem and about 5,000 of them die. The most common cause of this bleeding is stomach ulcers. In sub-Saharan Africa, schistosomiasis (parasitic worms) is responsible for about 130,000 deaths from stomach bleeding each year. From previous research in other bleeding conditions such as surgery and trauma, we know that a drug called tranexamic acid can reduce bleeding and save lives. We now want to do the HALT-IT trial to see if giving tranexamic acid can save lives and if there are any complications in people with severe bleeding from the digestive system.

Who can participate?
Adults with significant bleeding from any part of their digestive tract can take part in the HALT-IT trial. We plan to study 8,000 patients worldwide.

What does the study involve?
Adults (16 years or older) with significant bleeding from any part of their digestive tract can be part of the trial. Many patients will be admitted as an emergency with this bleeding problem and others might develop it in hospital. Because this bleeding is an emergency situation, doctors will need to decide very quickly whether a patient is suitable for the trial or not (usually as soon as possible after the problem is identified). Brief information will be collected on an entry form to see if a patient is suitable. In this emergency situation it is difficult for patients to give written informed consent to take part. We will therefore ask the ethics committee for permission to put patients into the trial without written consent but where possible will get agreement from patients and relatives first, and we will explain to patients later what happened to them and how the information from the trial will be used. We have asked the opinions of members of the public about this and they agree that this is the only way we can do good research on life threatening emergency problems.
Everyone will get all the treatments that doctors usually give for this condition. In addition, they will get the trial treatment by an intravenous infusion (drip) for about 8 hours. Half of the patients will receive tranexamic acid and the other half a dummy medicine called a placebo. To make sure that the two groups are the same apart from tranexamic acid, we will decide who gets tranexamic acid and who gets placebo using a computer programme, a modern equivalent of the toss of a coin (this is called randomisation).
We will collect some information on the progress of patients and whether they have any side effects in the trial up to 28 days. In some countries where health data is routinely stored on national databases, we will check the database to see whether patients had any illnesses recorded for up to one year. To allow us to do this, we will collect patients' personal information where we have been given approval to do so.

What are the possible benefits and risks of participating?
We hope that tranexamic acid will help reduce blood loss and reduce the number of patients who die from this condition. The knowledge that we gain from this study will help other people with gastrointestinal bleeding in the future.
Tranexamic acid is not a new drug. It has been used for years to reduce bleeding after operations and heavy menstruation and more recently to treat other types of serious injury. It works by stopping the breakdown of the blood clots which are needed to control bleeding. Studies have shown that it does not cause unwanted clotting and there are no serious side effects with short term use. However, patients will be monitored closely and will report to the study organisers if there are any unexpected problems.

Where is the study run from?
The HALT-it trial is organised by the London School of Hygiene and Tropical Medicine, UK and will involve hundreds of doctors and nurses worldwide.

When is study starting and how long is it expected to run for?
We plan to enter patients into the trial from January 2013 until October 2016.

Who is funding the study?
This study is funded by Health Technology Assessment programme which is part of the National Institute for Health Research (NIHR), UK.

Who is the main contact?
Professor Ian Roberts, haltit@lshtm.ac.uk
Ms Haleema Shakur, haltit@lshtm.ac.uk

Trial website

http://haltit.lshtm.ac.uk/

Contact information

Type

Scientific

Primary contact

Prof Ian Roberts

ORCID ID

Contact details

Clinical Trials Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7299 4684
haltit@lshtm.ac.uk

Additional identifiers

EudraCT number

2012-003192-19

ClinicalTrials.gov number

NCT01658124

Protocol/serial number

HTA 11/01/04

Study information

Scientific title

Tranexamic acid for the treatment of gastrointestinal haemorrhage: an international randomised, double blind placebo controlled trial

Acronym

HALT-IT

Study hypothesis

The HALT-IT trial will determine the effect of Tranexamic acid (TXA) on mortality, morbidity (re-bleeding, non-fatal vascular events), blood transfusion, surgical intervention and health status in patients with acute gastrointestinal haemorrhage.

More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/110104
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0018/81144/PRO-11-01-04.pdf

Ethics approval

Not provided at time of registration

Study design

Pragmatic randomised double blind placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Upper and lower gastrointestinal bleeding

Intervention

Tranexamic acid versus placebo

Patients will be randomised to either tranexamic acid (loading dose 1 gram over 10 minutes then infusion of 3 gram over 24 hours) or matching placebo (given by intravenous infusion).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Death in hospital within 28 days of randomisation (cause-specific mortality will also be recorded)

Secondary outcome measures

1. Re-bleeding
2. Need for salvage surgery or radiological intervention
3. Blood transfusion – blood or blood component units transfused
4. Thromboembolic events (myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis)
5. Other adverse medical events (including renal failure, significant cardiac event, respiratory failure, hepatic failure, sepsis, pneumonia, seizure)
6. Functional status measured using the Katz Index of Independence in Activities of Daily Living
7. Time spent at an intensive care unit
8. Length of stay in hospital
9. Patient status (death, hospital readmission) at 12 months will be ascertained if appropriate databases are available in the recruiting country

Overall trial start date

02/01/2013

Overall trial end date

31/10/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. All adult patients with acute significant upper or lower gastrointestinal bleeding
2. Where the responsible clinician is substantially uncertain as to the appropriateness of antifibrinolytic agents in the patient

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

8000

Participant exclusion criteria

The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use an antifibrinolytic agent in a particular patient with upper or lower gastrointestinal bleeding.

Recruitment start date

02/01/2013

Recruitment end date

31/10/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Trials Unit
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine (UK)

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7299 4684
haltit@lshtm.ac.uk

Sponsor type

University/education

Website

http://www.lshtm.ac.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) 11/01/04

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25409738

Publication citations

Additional files

Editorial Notes