Haemorrhage Alleviation With Tranexamic Acid- Intestinal System

NCT01658124 | Completed Phase 3 DMC

• 1 other identifier: ISRCTN11225767
• Study Type: interventional
• Target: 12,009
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastrointestinal Bleeding

Keywords

haemorrhage,antifibrinolytic, clinical trial,

Outcome Measures

Primary Outcomes (1)

• The primary outcome is death from haemorrhage

  within 5 days of randomisation

Secondary Outcomes (11)

• Death (all cause and cause specific)

  within 28 days of randomisation

• Death from haemorrhage

  within 28 days of randomisation

• Number of Patients with Re-bleeding

  within 5 and 28 days of randomisation

• Number of patients who had Endoscopic, radiological or surgical intervention for gastro intestinal bleeding

  within 28 days of randomisation

• Number of patients who had Blood transfusion

  within 28 days of randomisation

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

(total dose 8 grams)

Drug: Tranexamic Acid

Placebo

PLACEBO COMPARATOR

(Sodium Chloride 0.9%)

Drug: Placebo

Interventions

Tranexamic Acid DRUG

Tranexamic acid

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients
• with acute significant upper or lower gastrointestinal bleeding
• where the responsible clinician is substantially uncertain as to the appropriateness of antifibrinolytic agents in the patient

You may not qualify if:

• 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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Rawalpindi Medical College: collaborator
• University of Ibadan: collaborator

Study Sites (1)

Over 50 countries Worldwide

London, United Kingdom

Location

Related Publications (4)

• Roberts I, Shakur-Still H, Afolabi A, Akere A, Arribas M, Austin E, Bal K, Bazeer N, Beaumont D, Brenner A, Carrington L, Chaudhri R, Coats T, Gilmore I, Halligan K, Hussain I, Jairath V, Javaid K, Kayani A, Lisman T, Mansukhani R, Miners A, Mutti M, Nadeem MA, Pollok R, Prowse D, Simmons J, Stanworth S, Veitch A, Williams J. A high-dose 24-hour tranexamic acid infusion for the treatment of significant gastrointestinal bleeding: HALT-IT RCT. Health Technol Assess. 2021 Oct;25(58):1-86. doi: 10.3310/hta25580.

  PMID: 34663491 DERIVED

• HALT-IT Trial Collaborators. Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial. Lancet. 2020 Jun 20;395(10241):1927-1936. doi: 10.1016/S0140-6736(20)30848-5.

  PMID: 32563378 DERIVED

• Brenner A, Afolabi A, Ahmad SM, Arribas M, Chaudhri R, Coats T, Cuzick J, Gilmore I, Hawkey C, Jairath V, Javaid K, Kayani A, Mutti M, Nadeem MA, Shakur-Still H, Stanworth S, Veitch A, Roberts I; HALT-IT Trial Collaborators. Tranexamic acid for acute gastrointestinal bleeding (the HALT-IT trial): statistical analysis plan for an international, randomised, double-blind, placebo-controlled trial. Trials. 2019 Jul 30;20(1):467. doi: 10.1186/s13063-019-3561-7.

  PMID: 31362765 DERIVED

• Roberts I, Coats T, Edwards P, Gilmore I, Jairath V, Ker K, Manno D, Shakur H, Stanworth S, Veitch A. HALT-IT--tranexamic acid for the treatment of gastrointestinal bleeding: study protocol for a randomised controlled trial. Trials. 2014 Nov 19;15:450. doi: 10.1186/1745-6215-15-450.

  PMID: 25409738 DERIVED

Related Links

• Trial website

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Haleema Shakur-Still

  London School of Hygiene and Tropical Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: August 6, 2012
• Study Start: July 1, 2013
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: April 17, 2020

Record last verified: 2020-02

Locations

GB (1)