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Published on: September 20, 2019
Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a
Brennan C Kahan1, Vipul Jairath, Michael F Murphy
1MRC Clinical Trials Unit, Aviation House 125 Kingsway, London WC2B 6NH, UK. b.kahan@ucl.ac.uk
Trials
|July 11, 2013
Summary
This study evaluated transfusion policies for acute upper gastrointestinal bleeding (AUGIB). Restrictive red blood cell (RBC) transfusion may reduce risks compared to liberal policies in AUGIB patients.
Area of Science:
- Hematology
- Gastroenterology
- Clinical Trials
Background:
- Previous studies suggest liberal red blood cell (RBC) transfusion increases risks in acute upper gastrointestinal bleeding (AUGIB).
- Understanding optimal transfusion strategies is crucial for patient outcomes in AUGIB.
Purpose of the Study:
- To evaluate the feasibility of implementing restrictive versus liberal RBC transfusion policies in UK hospitals for AUGIB patients.
- To inform the design and methodology of a future phase III trial.
Main Methods:
- The Transfusion in Gastrointestinal Bleeding (TRIGGER) trial is a pragmatic cluster-randomised feasibility study.
- Recruitment occurred between September 2012 and March 2013.
- This update details the statistical analysis plan for transparency.
Main Results:
- Feasibility data on implementing transfusion policies will be analyzed.
- Statistical analysis plan ensures transparent evaluation of trial data.
Conclusions:
- The TRIGGER trial will provide essential feasibility data for a larger phase III study.
- Publication of the statistical analysis plan enhances transparency in clinical trial research.
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