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Restrictive versus liberal blood transfusion for acute upper gastrointestinal bleeding (TRIGGER): a pragmatic, open-label, cluster randomized feasibility trial

Journal Club Summary

Methodology Score: 3/5                   
Usefulness Score: 2/5

Jairath V, et al.
Lancet. 2015 Jul 11;386(9989):137-44

This open label, cluster randomized feasibility trial based in six university hospitals in the United Kingdom including 936 patients demonstrated no difference in measured clinical outcomes between the liberal and restrictive blood transfusion groups for acute upper gastrointestinal bleeds. Although this was a feasibility trial and many limitations of the study were identified (balance between clusters, adherence to protocol, contamination, loss to follow-up), it was felt even a large non-inferiority trial is unlikely to find a difference in patient outcomes with the two transfusion regimens.
By: Dr. Shannon McCarter

Epi lesson

Cluster Randomized Controlled Trials 
A cluster randomized trial is a trial in which individuals are randomized in groups (i.e. the group is randomized, not the individual); for example, all patients treated By: a particular EMS service or at a particular hospital. Reasons for performing cluster randomized trials vary. Sometimes the intervention can only be administered to the group, for example an addition to the water supply; sometimes the motivation is to avoid contamination amongst health care providers; sometimes the design is simply more convenient or economical. Such trials are often appropriate when the intervention is a psychomotor task (e.g. CPR) but not when the intervention is a drug. Specific sample size and data analytic approaches are required. 
By: Dr. Ian Stiell  

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