Statistical analysis plan for the POLAR-RCT: The Prophylactic hypOthermia trial to Lessen trAumatic bRain injury-Randomised Controlled Trial

DiscussionConsistent with international guidelines, a detailed and prospective analysis plan has been developed for the POLAR-RCT. This plan specifies the statistical models for evaluation of primary and secondary outcomes, as well as defining covariates for adjusted analyses and methods for exploratory analyses. Application of this statistical analysis plan to the forthcoming POLAR-RCT trial will facilitate unbiased analyses of these important clinical data.Trial registrationClinicalTrials.gov,NCT00987688 (first posted 1 October 2009); Australian New Zealand Clinical Trials Registry,ACTRN12609000764235. Registered on 3 September 2009.
Source: Trials - Category: Research Source Type: clinical trials