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Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a cluster-randomised feasibility trial
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Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a cluster-randomised feasibility trial
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Journal Article
Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a cluster-randomised feasibility trial
2013
Overview
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.
Trial registration
ISRCTN85757829
Publisher
BioMed Central,BioMed Central Ltd
Subject
/ Adult
/ Analysis
/ Data Interpretation, Statistical
/ Erythrocyte Transfusion - adverse effects
/ Erythrocyte Transfusion - methods
/ Erythrocyte Transfusion - mortality
/ Gastrointestinal Hemorrhage - mortality
/ Gastrointestinal Hemorrhage - therapy
/ Humans
/ Medicine
/ Research Design - statistics & numerical data
/ Statistics for Life Sciences
/ Update
