Protocol for a multicentre randomised controlled trial of early and sustained prophylactic hypothermia in the management of traumatic brain injury

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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.
Original languageEnglish
Pages (from-to)92 - 100
Number of pages9
JournalCritical Care and Resuscitation
Volume17
Issue number2
Publication statusPublished - 2015

Cite this

@article{a66b493ea33346588d44b644209aad6b,
title = "Protocol for a multicentre randomised controlled trial of early and sustained prophylactic hypothermia in the management of traumatic brain injury",
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.",
author = "Nichol, {Alistair Dualta} and Dashiell Gantner and Presneill, {Jeffrey J} and Murray, {Lynnette Joy} and Tony Trapani and Bernard, {Stephen Anthony} and Peter Cameron and Gilles Capellier and Forbes, {Andrew Benjamin} and Colin McArthur and Lynette Newby and Stephen Rashford and Rosenfeld, {Jeffrey Victor} and Tony Smith and Stephenson, {Michael William} and Varma, {Dinesh Kumar} and Walker, {Tony L J} and Webb, {Steven A R} and Cooper, {David James}",
year = "2015",
language = "English",
volume = "17",
pages = "92 -- 100",
journal = "Critical Care and Resuscitation",
issn = "1441-2772",
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T1 - Protocol for a multicentre randomised controlled trial of early and sustained prophylactic hypothermia in the management of traumatic brain injury

AU - Nichol, Alistair Dualta

AU - Gantner, Dashiell

AU - Presneill, Jeffrey J

AU - Murray, Lynnette Joy

AU - Trapani, Tony

AU - Bernard, Stephen Anthony

AU - Cameron, Peter

AU - Capellier, Gilles

AU - Forbes, Andrew Benjamin

AU - McArthur, Colin

AU - Newby, Lynette

AU - Rashford, Stephen

AU - Rosenfeld, Jeffrey Victor

AU - Smith, Tony

AU - Stephenson, Michael William

AU - Varma, Dinesh Kumar

AU - Walker, Tony L J

AU - Webb, Steven A R

AU - Cooper, David James

PY - 2015

Y1 - 2015

N2 - 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.

AB - 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.

UR - http://www.ncbi.nlm.nih.gov/pubmed/26017126

M3 - Article

VL - 17

SP - 92

EP - 100

JO - Critical Care and Resuscitation

JF - Critical Care and Resuscitation

SN - 1441-2772

IS - 2

ER -