Haemorrhage ALleviation with Tranexamic acid ? IntesTinal system

Phase 3

Completed

• Conditions: pper and lower gastrointestinal bleeding; Haematological Disorders

• Registration Number: ISRCTN11225767
• Lead Sponsor: ondon School of Hygiene and Tropical Medicine (UK)

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25409738 2019 statistical analysis plan in: https://www.ncbi.nlm.nih.gov/pubmed/31362765 (added 01/08/2019) 2020 results in https://doi.org/10.1016/S0140-6736(20)30848-5 (added 23/07/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-03
• Study Completion: 2019-07-19
• Last Update Posted: 5 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12009

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Current primary outcome measure as of 30/04/2019:<br> 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)<br><br> Previous primary outcome measure:<br> 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)<br>