Haemorrhage Alleviation With Tranexamic Acid- Intestinal System

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01658124
• Date of registration: 26/07/2012
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: Haemorrhage Alleviation With Tranexamic Acid- Intestinal System HALT-IT
• Scientific title: Tranexamic Acid for the Treatment of Gastrointestinal Haemorrhage: an International Randomised, Double Blind Placebo Controlled Trial
• Date of first enrolment: July 2013
• Target sample size: 12009
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01658124
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

United Kingdom

Contacts

• Name: Haleema Shakur-Still
• Affiliation: LSHTM

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

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.

- There are no other exclusions.



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Gastrointestinal Bleeding

Intervention(s)

Drug: Tranexamic Acid

Drug: Placebo

Primary Outcome(s)

The primary outcome is death from haemorrhage [Time Frame: within 5 days of randomisation]

Secondary Outcome(s)

Functional status measured using the Katz Index of Independence in Activities of Daily Living [Time Frame: within 28 days of randomisation]

Number of patients who had Endoscopic, radiological or surgical intervention for gastro intestinal bleeding [Time Frame: within 28 days of randomisation]

Death from haemorrhage [Time Frame: within 28 days of randomisation]

Number of patients with Other adverse medical events [Time Frame: within 28 days of randomisation]

Length of stay in hospital [Time Frame: within 28 days of randomisation]

Number of patients with Thromboembolic events [Time Frame: within 28 days of randomisation]

Number of Patients with Re-bleeding [Time Frame: within 5 and 28 days of randomisation]

Patient status (death, hospital readmission) [Time Frame: within 12 months of randomisation]

Death (all cause and cause specific) [Time Frame: within 28 days of randomisation]

Number of patients who had Blood transfusion [Time Frame: within 28 days of randomisation]

Time spent at an intensive care or high dependency unit [Time Frame: within 28 days of randomisation]

Secondary ID(s)

ISRCTN11225767

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Ibadan

Rawalpindi Medical College