Status:
COMPLETED
Hypothermia in Traumatic Brain Injury in Children (HiTBIC)
Lead Sponsor:
Australia and New Zealand Intensive Care Society
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
1-16 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is: * To determine the safety and feasibility of performing an international multi-centre randomized control trial of early and prolonged hypothermia to improve outcome in c...
Detailed Description
We propose to do a pilot study of 50 children admitted with severe TBI to paediatric intensive care units in Australia and New Zealand. Severe TBI will be defined as children with either (i) Glasgow C...
Eligibility Criteria
Inclusion
- have a severe traumatic brain injury as defined by either a GCS ≤ 8 and an abnormal CT scan (intracranial hemorrhage, cerebral edema or diffuse axonal injury) or a motor score ≤ 3 and normal CT scan
- are aged between 1 and 16 years
- are mechanically ventilated
Exclusion
- are not randomized by 6 hours after injury
- have penetrating brain injuries
- have fixed dilated pupils and GCS = 3
- have proven cervical spinal cord injury
- have more than mild neurodevelopmental disability prior to injury
- have an acute isolated epidural hematoma and are expected to recover rapidly after surgical removal
- have had a post-traumatic seizure with a normal CT scan
- have refractory shock, defined as systolic blood pressure more than 2 standard deviations (SD) below the mean for age despite 80ml/kg intravenous fluid resuscitation
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00282269
Start Date
November 1 2006
End Date
June 1 2010
Last Update
June 22 2010
Active Locations (7)
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1
Royal Alexandra Hospital for Children
Sydney, New South Wales, Australia
2
Sydney Children's Hospital
Sydney, New South Wales, Australia
3
Queensland Paediatric Intensive Care Services
Brisbane, Queensland, Australia
4
Women's and Children's Hospital
Adelaide, South Australia, Australia