Transfusion in Gastrointestinal Bleeding (TRIGGER)

Not Applicable

Completed

• Conditions: on-malignant haematology; Surgery

• Registration Number: ISRCTN85757829
• Lead Sponsor: HS Blood and Transplant Research & Development (UK)

Brief Summary

2013 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/23706959 2013 statistical analysis plan in: http://www.ncbi.nlm.nih.gov/pubmed/23837630 2014 strategies in: http://www.ncbi.nlm.nih.gov/pubmed/25416527 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25926146 2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25956718

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-26
• Study Completion: 2013-02-01
• Last Update Posted: 16 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 849

Inclusion Criteria

1. Adults aged = 18 years presenting with AUGIB, defined by haematemesis or melaena.
2. >20 admissions with AUGIB per month
3. >400 hospital beds
4. Availability of 24 hours endoscopy and on-site access to intensive care and surgical support
5. Institutional agreement to transfuse all eligible new admissions with AUGIB in accordance with the randomised transfusion policy
6. Male & female participants
7. Lower Age Limit 18 years

Exclusion Criteria

1. Patients for whom the responsible clinician considers there is a need for immediate RBC transfusion prior to obtaining or regardless of the initial Haemoglobin (Hb) result due to severity of bleeding (these patients should be managed according to the hospital's massive transfusion protocol or clinician discretion)
2. Existing hospital inpatients who develop an AUGIB

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Protocol adherence<br> 2. Selection bias<br> 3. Recruitment rate<br> 4. Red cell exposure<br> 5. Information to inform the sample size of the phase III trial<br><br> Clinical Outcomes: Further bleeding up to Day 28: Further bleeding is a composite outcome that includes persistent bleeding<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Further bleeding<br> 2. 28-day mortality<br> 3. Infections<br> 4. Ischaemic/thromboembolic events<br><br> We will also collect data to guide a Health Economic evaluation for the phase III trial.<br>