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

Phase 1

• Conditions: 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]

• Registration Number: EUCTR2012-003192-19-GB
• Lead Sponsor: ondon School Of Hygiene and Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-02-15
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 12000

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified