Journal article
Protocol for a multicentre randomised controlled trial of early and sustained prophylactic hypothermia in the management of traumatic brain injury
A Nichol, D Gantner, J Presneill, L Murray, T Trapani, S Bernard, P Cameron, G Capellier, A Forbes, C McArthur, L Newby, S Rashford, JV Rosenfeld, T Smith, M Stephenson, D Varma, T Walker, DJ Cooper
Critical Care and Resuscitation | AUSTRALASIAN MED PUBL CO LTD | Published : 2015
Abstract
Introduction: Traumatic brain injury (TBI) is a leading cause of death and disability worldwide. Prophylactic hypothermia is effective in laboratory models, but clinical studies to date have been inconclusive, partly because of methodological limitations. Our Prophylactic Hypothermia Trial to Lessen Traumatic Brain Injury (POLAR) randomised controlled trial is currently underway comparing early, sustained hypothermia versus standard care in patients with severe TBI. We describe our study protocol and the challenges in conducting prophylactic hypothermia research in TBI. Design: We aim to randomise 500 patients to either prophylactic 33°C hypothermia initiated within 3 hours of injury and con..
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Funding Acknowledgements
The POLAR RCT is funded by the Australian National Health and Medical Research Council and the Victorian Transport Accident Commission. The cooling vests and blankets are purchased and maintained using project grant funds. Funding agencies and cooling device suppliers and manufacturers have not had and will not have any role in study design, data collection, data analysis or writing of manuscripts.