Update on the transfusion in gastrointestinal bleeding (TRIGGER) trial: statistical analysis plan for a cluster-randomised feasibility trial

Trials

Caroline J Doré¹  Michael F Murphy²  Vipul Jairath³  Brennan C Kahan¹ 

[1]MRC Clinical Trials Unit, Aviation House 125 Kingsway, London WC2B 6NH, UK

[2]University of Oxford, Oxford, UK

[3]Translational Gastroenterology Unit, Oxford, UK

关键词: Feasibility trial;    Variceal bleeding;    Gastrointestinal bleeding;    Transfusion;    Cluster randomised trial;    Statistical analysis plan;   

Others  :  1093489
DOI  :  10.1186/1745-6215-14-206

 received in 2013-03-08, accepted in 2013-06-27,  发布年份 2013

【 摘 要 】

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

【 授权许可】

   
2013 Kahan et al.; licensee BioMed Central Ltd.

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