Journal article
Statistical analysis plan for the POLAR-RCT: The Prophylactic hypOthermia trial to Lessen trAumatic bRain injury-Randomised Controlled Trial
J Presneill, D Gantner, A Nichol, C McArthur, A Forbes, J Kasza, T Trapani, L Murray, S Bernard, P Cameron, G Capellier, O Huet, L Newby, S Rashford, JV Rosenfeld, T Smith, M Stephenson, D Varma, S Vallance, T Walker Show all
Trials | BMC | Published : 2018
Open access
Abstract
Background: The Prophylactic hypOthermia to Lessen trAumatic bRain injury-Randomised Controlled Trial (POLAR-RCT) will evaluate whether early and sustained prophylactic hypothermia delivered to patients with severe traumatic brain injury improves patient-centred outcomes. Methods: The POLAR-RCT is a multicentre, randomised, parallel group, phase III trial of early, prophylactic cooling in critically ill patients with severe traumatic brain injury, conducted in Australia, New Zealand, France, Switzerland, Saudi Arabia and Qatar. A total of 511 patients aged 18-60 years have been enrolled with severe acute traumatic brain injury. The trial intervention of early and sustained prophylactic hypot..
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Awarded by National Health and Medical Research Council
Funding Acknowledgements
Funding for this investigator-initiated research is sourced in Australia from the National Health and Medical Research Council (Project Grant ID 545901) and the Victorian Transport Accident Commission (formerly Victorian Neurotrauma Initiative; Project Grant ID D162). Trial design, data collection and analyses will be undertaken independent of the funding bodies. The POLAR-RCT trial is co-ordinated by the Australian and New Zealand Intensive Care-Research Centre, Monash University, Melbourne and endorsed by the Australian and New Zealand Intensive Care Society Clinical Trials Group. POLAR-RCT is managed in France by the Centre Hospitalier Regional Universitaire (CHRU) Besancon. The members of the Management Committee are listed in Additional file 6. The POLAR-RCT trial sites, principal investigator(s) and research coordinator(s) are listed in Additional file 7.