Journal
TRIALS
Volume 14, Issue -, Pages -Publisher
BIOMED CENTRAL LTD
DOI: 10.1186/1745-6215-14-206
Keywords
Statistical analysis plan; Cluster randomised trial; Transfusion; Gastrointestinal bleeding; Variceal bleeding; Feasibility trial
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Funding
- NHS Blood and Transplant RD Committee [10-09-CSU]
- MRC [MC_U122870183] Funding Source: UKRI
- Medical Research Council [MC_U122870183] Funding Source: researchfish
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Background: Previous research has suggested an association between more liberal red blood cell (RBC) transfusion and greater risk of further bleeding and mortality following acute upper gastrointestinal bleeding (AUGIB). Methods and design: The Transfusion in Gastrointestinal Bleeding (TRIGGER) trial is a pragmatic cluster-randomised feasibility trial which aims to evaluate the feasibility of implementing a restrictive vs. liberal RBC transfusion policy for adult patients admitted to hospital with AUGIB in the UK. This trial will help to inform the design and methodology of a phase III trial. The protocol for TRIGGER has been published in Transfusion Medicine Reviews. Recruitment began in September 2012 and was completed in March 2013. This update presents the statistical analysis plan, detailing how analysis of the TRIGGER trial will be performed. It is hoped that prospective publication of the full statistical analysis plan will increase transparency and give readers a clear overview of how TRIGGER will be analysed.
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