Emergency medicine Australasia : EMA
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Emerg Med Australas · Oct 2013
Randomized Controlled Trial Multicenter StudyAustralasian Resuscitation In Sepsis Evaluation trial statistical analysis plan.
The Australasian Resuscitation In Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the ED with severe sepsis. ⋯ A statistical analysis plan for the ARISE study has been developed, and is available in the public domain, prior to the completion of recruitment into the study. This will minimise analytic bias and conforms to current best practice in conducting clinical trials.