Tranexamic Acid for the treatment of significant gastrointestinal bleeding (bleeding from the gut) - HALT-IT

• Register: EUCTR
• Last refreshed on: 16 December 2019
• Main ID: EUCTR2012-003192-19-GB
• Date of registration: 15/02/2013
• Prospective Registration: Yes
• Primary sponsor: London School Of Hygiene and Tropical Medicine
• Public title: Tranexamic Acid for the treatment of significant gastrointestinal bleeding (bleeding from the gut) - HALT-IT
• Scientific title: Tranexamic acid for the treatment of gastrointestinal haemorrhage: an international randomised, double blind placebo controlled trial - Haemorrhage alleviation with tranexamic acid [HALT-IT] [Version 1.0]
• Date of first enrolment: 22/02/2013
• Target sample size: 12000
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003192-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Albania, Australia, Belgium, Egypt, Georgia, India, Ireland, Italy, Jamaica, Mexico, Nigeria, Pakistan, Romania, Saudi Arabia, Spain, Sudan, Uganda, United Kingdom

Contacts

• Name: Haleema Shakur
• Affiliation: London School Of Hygiene and Tropical Medicine

• Name: Haleema Shakur
• Affiliation: London School Of Hygiene and Tropical Medicine

Key inclusion & exclusion criteria

Inclusion criteria:
• Adult (16 years and over) with significant gastrointestinal bleeding
• Where the responsible clinician is substantially uncertain as to whether or not to use tranexamic acid


Are the trial subjects under 18? yes
Number of subjects for this age range: 300
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5700
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6000

Exclusion criteria:
• Patients for whom the responsible clinician considers there is a clear indication for tranexamic acid.
• Patients for whom the responsible clinician considers there is a clear contraindication for tranexamic acid.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Gastrointestinal hemorrhage
MedDRA version: 20.1 Level: LLT Classification code 10017960 Term: Gastrointestinal hemorrhage System Organ Class: 100000004856

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Intervention(s)

Trade Name: Cyklokapron
Product Name: Cyklokapron
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: Tranexamic Acid
CAS Number: 1197-18-8
Current Sponsor code: ISRCTN11225767
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100 mg-1 ml
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)

Main Objective: The HALT-IT trial will find out whether early administration of tranexamic acid improves outcomes for people who suffered of significant gastrointestinal bleeding. The main outcome is death from haemorrhage within 5 days of randomisation. We will also assess the cause of death.

Timepoint(s) of evaluation of this end point: 28 days after randomisation, at hospital discharge, or at death whichever occurs first).

Secondary Objective: The secondary objectives will be to assess death from haemorrhage within 28 days of randomisation, all-cause mortality and cause-specific mortality within 28 days of randomisation, and whether tranexamic acid leads to better outcomes such as reducing re-bleeding, need for endoscopy, surgery or radiological intervention, blood transfusion, number of days spent in intensive care. We will also assess whether there is any increase in serious outcomes including heart attack, stroke and blood clots in the legs or lungs, and seizures. In addition, we will evaluate if there is an improvement in patient's ability to perform the activities of daily living at discharge (bathing, dressing, toileting, transferring, continence and feeding) and patients' health status after 1 year.

Primary end point(s): The primary outcome is death from haemorrhage within 5 days after randomisation (all-cause and cause-specific mortality will also be recorded).

Secondary Outcome(s)

Secondary end point(s): a) Death from haemorrhage within 28 days of randomisation
b) Mortality: all-cause and cause-specific mortality within 28 days of randomisation
c) Re-bleeding
d) Need for endoscopy, surgery or radiological intervention
e) Blood product transfusion
f) Thromboembolic events (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction)
g) Other complications (including other significant cardiac event, sepsis, pneumonia, respiratory failure, renal failure, liver failure, seizures)
h) Functional status will be measured by the Katz Index of Independence in Activities of Daily Living at discharge from the randomising hospital or in-hospital at 28 days after randomisation. The Index assesses adequacy of performance in six functions of bathing, dressing, toileting, transferring, continence and feeding. Patients are scored ‘yes’ or ‘no’ for independence in each of the functions (score of 6=full function, 4=moderate impairment, and =2=severe functional impairment)
i) Days spent in intensive care unit or high dependency unit
j) Patient status (death, hospital readmission) at 12 months

Timepoint(s) of evaluation of this end point: 28 days after randomisation, at discharge from the randomising hospital, or at death (whichever occurs first) for all the above secondary outcome, except (j) "Patient status (death, hospital readmission) at 12 months", which will be evaluated at 12 months after randomisation.

Secondary ID(s)

NCT01658124

ISRCTN11225767

Source(s) of Monetary Support

NIHR-HTA

Ethics review

Status: Approved
Approval date:
Contact: