Haemorrhage ALleviation with Tranexamic acid IntesTinal system
| ISRCTN | ISRCTN11225767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11225767 |
| EudraCT/CTIS number | 2012-003192-19 |
| ClinicalTrials.gov number | NCT01658124 |
| Secondary identifying numbers | Version 3.0 29/01/2019 |
- Submission date
- 26/06/2012
- Registration date
- 03/07/2012
- Last edited
- 25/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
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 12,000 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 24 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 May 2019.
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
Contact information
Scientific
Clinical Trials Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
| Phone | +44 (0)20 7299 4684 |
|---|---|
| haltit@lshtm.ac.uk |
Study information
| Study design | Pragmatic randomised double blind placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Tranexamic acid for the treatment of gastrointestinal haemorrhage: an international randomised, double blind placebo controlled trial |
| Study 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(s) | LSHTM ethics committee, 19/12/2012, ref:6328 |
| Condition | Upper and lower gastrointestinal bleeding |
| Intervention | Tranexamic acid versus placebo Patients will be randomised to either tranexamic acid (loading dose 1 g over 10 min then infusion of 3 g over 24 h) or matching placebo (given by intravenous infusion). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Tranexamic acid |
| Primary outcome measure | Current primary outcome measure as of 30/04/2019: Death from haemorrhage within 5 days of randomisation (all-cause and cause-specific mortality within 28 days will also be recorded: haemorrhage, myocardial infarction, stroke, pulmonary embolism, pneumonia, malignancy, other) Previous primary outcome measure: Death in hospital within 28 days of randomisation (cause-specific mortality will also be recorded: haemorrhage, myocardial infarction, stroke, pulmonary embolism, pneumonia, malignancy, other) (Criteria added 01/12/2017) |
| Secondary outcome measures | Current secondary outcome measures as of 30/04/2019: 1. Death from haemorrhage within 28 days 2. Re-bleeding 3. Endoscopic, radiological or surgical intervention 4. Blood transfusion blood or blood component units transfused 5. Thromboembolic events (myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis) 6. Complications (including renal failure, significant cardiac event, respiratory failure, hepatic failure, sepsis, pneumonia, seizure) 7. Functional status measured using the Katz Index of Independence in Activities of Daily Living 8. Time spent at an intensive care or high dependency unit 9. Length of stay in hospital 10. Patient status (death, hospital readmission) at 12 months will be ascertained if appropriate databases are available in the recruiting country 11. Adverse events Previous secondary outcome measures: 1. Death from haemorrhage (added 01/12/2017) 2. Re-bleeding 3. Need for salvage surgery or radiological intervention 4. Blood transfusion blood or blood component units transfused 5. Thromboembolic events (myocardial infarction, stroke, pulmonary embolism, deep vein thrombosis) 6. Other adverse medical events (including renal failure, significant cardiac event, respiratory failure, hepatic failure, sepsis, pneumonia, seizure) 7. Functional status measured using the Katz Index of Independence in Activities of Daily Living 8. Time spent at an intensive care unit 9. Length of stay in hospital 10. Patient status (death, hospital readmission) at 12 months will be ascertained if appropriate databases are available in the recruiting country |
| Overall study start date | 02/01/2013 |
| Overall study end date | 19/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 12000 |
| Total final enrolment | 12009 |
| 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 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 | 21/06/2019 |
Locations
Countries of recruitment
- Australia
- Egypt
- England
- Georgia
- Ireland
- Malaysia
- Nepal
- Pakistan
- Papua New Guinea
- Romania
- Spain
- United Kingdom
Study participating centre
WC1E 7HT
United Kingdom
Sponsor information
University/education
Keppel Street
London
WC1E 7HT
England
United Kingdom
| Phone | +44 (0)20 7299 4684 |
|---|---|
| haltit@lshtm.ac.uk | |
| Website | http://www.lshtm.ac.uk/ |
"ROR" |
https://ror.org/00a0jsq62 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 20/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 19/11/2014 | Yes | No | |
| Statistical Analysis Plan | statistical analysis plan | 30/07/2019 | 01/08/2019 | No | No |
| Results article | results | 01/06/2020 | 23/07/2020 | Yes | No |
Editorial Notes
25/09/2020: The following changes have been made:
1. The recruitment end date has been changed from 30/09/2019 to 21/06/2019.
2. The overall trial end date has been changed from 30/09/2020 to 19/07/2019.
3. The intention to publish date has been changed from 30/09/2021 to 20/06/2020.
23/07/2020: Publication reference added.
18/11/2019: The following changes were made to the trial record:
1. The total final enrolment number was added.
2. The intention to publish date was added.
01/08/2019: Publication reference added.
30/04/2019: The following changes were made to the trial record:
1. The primary outcome measure was changed.
2. The secondary outcome measures were changed.
3. The recruitment end date was changed from 31/10/2017 to 30/09/2019.
4. The protocol number was changed from HTA 11/01/04 to Version 3.0 29/01/2019.
01/12/2017: Following changes have been made:
1. The target number of participants has been changed from 8000 to 12000
2. The cause-specific mortality criteria has been added to the primary outcome measure
3. Death from haemorrhage has been added as the main secondary outcome.
4. The recruitment end date has been extended from 31/10/2017 to 31/05/2019
5. The overall trial end date has been updated from 31/10/2017 to 30/09/2020.
6. Ethics approval information has been added.
7. Countries of recruitment were added
8. Plain English summary was updated accordingly.
