ANZICS CTG Endorsed Study

POLAR

Prophylactic hypothermia to lessen traumatic brain injury

Study Description

The POLAR trial is a multicenter, randomised controlled trial of early and sustained prophylactic hypothermia in patients with severe traumatic brain injury. The primary aim of the study is to determine whether early and sustained prophylactic hypothermia, compared to standard normothermic care, is associated with an increased proportion of favourable neurological outcomes for patients six months after severe traumatic brain injury.

Management Committee

Jamie Cooper (Chair), Peter Cameron, Gilles Capellier, Andrew Forbes, Colin McArthur, Lynne Murray, Lynette Newby, Alistair Nichol, Jeff Presneill, Stephen Rashford, Jeffrey Rosenfeld, Tony Smith, Michael Stephenson, Shirley Vallance, Dinesh Varma, Tony Walker, and Steve Webb.

Project Manager

Tony Trapani

Administering Institution

ANZIC Research Centre, Monash University

Sample Size

510 patients

Funding

National Health and Medical Research Council Project Grant $1,958,075
National Health and Medical Research Council Project Grant (POLAR II) $266,321
Transport Accident Commission (formerly Victorian Neurotrauma Initiative) $669,970

Project Status as of June 2018

510 patients have been recruited – final patient recruited November 2017. Average recruitment rate was 6 patients per month. Average over final 18 months was 7.8 patients per month. Due to increase in Northern hemisphere sites.

6 month follow-up is completed. It is hoped that results will be available for presentation at the ANZICS CTG Winter Research Forum 2018.

Contact

Tony Trapani (email)

Reference

CTG08-02
NCT 00987688
ACTRN12609000764235