Alistair Nichol1, Dashiell Gantner2, Jeffrey Presneill2, Lynnette Murray2, Tony Trapani2, Stephen Bernard3, Peter Cameron4, Gilles Capellier5, Andrew Forbes2, Colin McArthur2, Lynette Newby6, Stephen Rashford7, Jeffrey V Rosenfeld8, Tony Smith6, Michael Stephenson2, Dinesh Varma8, Tony Walker9, Steve Webb2, D James Cooper2. 1. Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia. Jamie.cooper@monash.edu. 2. Australian and New Zealand Intensive Care Research Centre, Monash University, Melbourne, VIC, Australia. 3. Department of Intensive Care, The Alfred Hospital, Melbourne, VIC, Australia. 4. Centre of Excellence in Traumatic Brain Injury Research, The Alfred Hospital, Monash University, Melbourne, VIC, Australia. 5. Réanimation médicale CHRU, H^pital Jean Minjoz, Besançon, France. 6. Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand. 7. Queensland Ambulance Service, Brisbane, QLD, Australia. 8. Department of Surgery, Monash University, Melbourne, VIC, Australia. 9. Department of Intensive Care, Royal Brisbane and Women's Hospital, Brisbane, QLD, Australia.
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 continued for at least 72 hours, or standard normothermic management. Patients will be enrolled by paramedic services in the prehospital setting, or by emergency department staff at participating sites in Australia, New Zealand and Europe. The primary outcome will be the eight-level extended Glasgow outcome scale (GOSE), dichotomised to favourable and unfavourable outcomes at 6 months after injury. Secondary outcomes will include mortality at hospital discharge and at 6 months, ordinal analyses of 6-month GOSE outcomes, quality of life with health economic evaluations and the differential proportion of adverse events. We will predefine subgroup and interaction analyses. DISCUSSION: After a run-in phase, recruitment for our main study began in December 2010. When the study is completed, we aim to provide evidence on the efficacy of prophylactic hypothermia in TBI to guide clinicians in their management of this devastating condition.
RCT Entities:
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 continued for at least 72 hours, or standard normothermic management. Patients will be enrolled by paramedic services in the prehospital setting, or by emergency department staff at participating sites in Australia, New Zealand and Europe. The primary outcome will be the eight-level extended Glasgow outcome scale (GOSE), dichotomised to favourable and unfavourable outcomes at 6 months after injury. Secondary outcomes will include mortality at hospital discharge and at 6 months, ordinal analyses of 6-month GOSE outcomes, quality of life with health economic evaluations and the differential proportion of adverse events. We will predefine subgroup and interaction analyses. DISCUSSION: After a run-in phase, recruitment for our main study began in December 2010. When the study is completed, we aim to provide evidence on the efficacy of prophylactic hypothermia in TBI to guide clinicians in their management of this devastating condition.
Authors: Jonathan Marehbian; Susanne Muehlschlegel; Brian L Edlow; Holly E Hinson; David Y Hwang Journal: Neurocrit Care Date: 2017-12 Impact factor: 3.210
Authors: D James Cooper; Alistair D Nichol; Michael Bailey; Stephen Bernard; Peter A Cameron; Sébastien Pili-Floury; Andrew Forbes; Dashiell Gantner; Alisa M Higgins; Olivier Huet; Jessica Kasza; Lynne Murray; Lynette Newby; Jeffrey J Presneill; Stephen Rashford; Jeffrey V Rosenfeld; Michael Stephenson; Shirley Vallance; Dinesh Varma; Steven A R Webb; Tony Trapani; Colin McArthur Journal: JAMA Date: 2018-12-04 Impact factor: 56.272
Authors: Sharon R Lewis; David Jw Evans; Andrew R Butler; Oliver J Schofield-Robinson; Phil Alderson Journal: Cochrane Database Syst Rev Date: 2017-09-21
Authors: Jeffrey Presneill; Dashiell Gantner; Alistair Nichol; Colin McArthur; Andrew Forbes; Jessica Kasza; Tony Trapani; Lynnette Murray; Stephen Bernard; Peter Cameron; Gilles Capellier; Olivier Huet; Lynette Newby; Stephen Rashford; Jeffrey V Rosenfeld; Tony Smith; Michael Stephenson; Dinesh Varma; Shirley Vallance; Tony Walker; Steve Webb; D James Cooper Journal: Trials Date: 2018-04-27 Impact factor: 2.279