Hypothermia for traumatic brain injury in children - a Phase II randomized controlled trial

Beca, John, McSharry, Brent, Erickson, Simon, Yung, Michael, Schibler, Andreas, Slater, Anthony, Wilkins, Barry, Singhal, Ash, Williams, Gary, Sherring, Claire and Butt, Warwick (2015) Hypothermia for traumatic brain injury in children - a Phase II randomized controlled trial. Critical Care Medicine, 43 7: 1458-1466. doi:10.1097/CCM.0000000000000947

Attached Files (Some files may be inaccessible until you login with your UQ eSpace credentials)
Name Description MIMEType Size Downloads

Author Beca, John
McSharry, Brent
Erickson, Simon
Yung, Michael
Schibler, Andreas
Slater, Anthony
Wilkins, Barry
Singhal, Ash
Williams, Gary
Sherring, Claire
Butt, Warwick
Title Hypothermia for traumatic brain injury in children - a Phase II randomized controlled trial
Journal name Critical Care Medicine   Check publisher's open access policy
ISSN 1530-0293
Publication date 2015-07-21
Year available 2015
Sub-type Article (original research)
DOI 10.1097/CCM.0000000000000947
Open Access Status Not Open Access
Volume 43
Issue 7
Start page 1458
End page 1466
Total pages 9
Place of publication Philadelphia, PA United States
Publisher Lippincott Williams &Wilkins
Language eng
Formatted abstract
Objectives: To perform a pilot study to assess the feasibility of performing a phase III trial of therapeutic hypothermia started early and continued for at least 72 hours in children with severe traumatic brain injury.

Design: Multicenter prospective randomized controlled phase II trial.

Setting: All eight of the PICUs in Australia and New Zealand and one in Canada.

Patients: Children 1–15 years old with severe traumatic brain injury and who could be randomized within 6 hours of injury.

Interventions: The control group had strict normothermia to a temperature of 36–37°C for 72 hours. The intervention group had therapeutic hypothermia to a temperature of 32–33°C for 72 hours followed by slow rewarming at a rate compatible with maintaining intracranial pressure and cerebral perfusion pressure.

Measurements and Main Results: Of 764 children admitted to PICU with traumatic brain injury, 92 (12%) were eligible and 55 (7.2%) were recruited. There were five major protocol violations (9%): three related to recruitment and consent processes and two to incorrect temperature management. Rewarming took a median of 21.5 hours (16–35 hr) and was performed without compromise in the cerebral perfusion pressure. There was no increase in any complications, including infections, bleeding, and arrhythmias. There was no difference in outcomes 12 months after injury; in the therapeutic hypothermia group, four (17%) had a bad outcome (pediatric cerebral performance category, 4–6) and three (13%) died, whereas in the normothermia group, three (12%) had a bad outcome and one (4%) died.

Conclusions: Early therapeutic hypothermia in children with severe traumatic brain injury does not improve outcome and should not be used outside a clinical trial. Recruitment rates were lower and outcomes were better than expected. Conventional randomized controlled trials in children with severe traumatic brain injury are unlikely to be feasible. A large international trials group and alternative approaches to trial design will be required to further inform practice.
Keyword Children
Pediatric intensive care
Randomized controlled trial
Therapeutic hypothermia
Traumatic brain injury
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Mater Research Institute-UQ (MRI-UQ)
Official 2016 Collection
School of Medicine Publications
Version Filter Type
Citation counts: TR Web of Science Citation Count  Cited 15 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 16 times in Scopus Article | Citations
Google Scholar Search Google Scholar
Created: Sun, 23 Aug 2015, 10:16:01 EST by System User on behalf of School of Medicine