Status:
COMPLETED
The Prophylactic Hypothermia Trial to Lessen Traumatic Brain Injury
Lead Sponsor:
Australian and New Zealand Intensive Care Research Centre
Collaborating Sponsors:
Australian and New Zealand Intensive Care Society Clinical Trials Group
National Health and Medical Research Council, Australia
Conditions:
Brain Injuries, Traumatic
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Traumatic brain injury (TBI) is a leading cause of death and long term disability, particularly in young adults. Studies from Australia have shown that approximately half of those with severe traumati...
Detailed Description
Eligible patients will be randomised in the pre-hospital setting or on admission to the Emergency Department. POLAR study trained paramedics and physicians will screen patients in the pre-hospital set...
Eligibility Criteria
Inclusion
- Blunt trauma with clinical diagnosis of severe TBI and GCS \<9
- Estimated age ≥ 18 and \< 60 years of age
- The patient is intubated or intubation is imminent
Exclusion
- Pre-hospital:
- Clinical diagnosis of drug or alcohol intoxication as predominant cause of coma
- Randomisation unable to be performed within 3 hrs of estimated time of injury
- Estimated transport time to study hospital \>2.5hrs
- Able to be intubated without drugs
- Systolic BP \<90mmHg
- Heart rate \> 120bpm
- GCS=3 + un-reactive pupils
- Penetrating neck/torso injury
- Known or obvious pregnancy
- Receiving hospital is not a study site
- Evidence of current anti-coagulant treatment
- Emergency Dept:
- Clinical diagnosis of drug or alcohol intoxication as predominant cause of coma
- Randomisation unable to be performed within 3 hrs of estimated time of injury
- Able to be intubated without drugs
- GCS=3 + un-reactive pupils
- Persistent Systolic BP \<90mmHg
- Clinically significant bleeding likely to require haemostatic intervention, for example:
- Bleeding into the chest, abdomen or retro-peritoneum likely to require surgery +/- embolisation
- Pelvic fracture likely to require surgery +/- embolisation
- More than two long bone fractures requiring operative fixation
- Penetrating neck/torso injury
- Positive urine or blood pregnancy test
- Evidence of current anti-coagulant treatment
- In the treating clinician's opinion, "cooling" is not in the patient's best interest
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2018
Estimated Enrollment :
511 Patients enrolled
Trial Details
Trial ID
NCT00987688
Start Date
April 1 2010
End Date
June 15 2018
Last Update
August 22 2018
Active Locations (15)
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1
Princess Alexandra Hospital
Brisbane, Queensland, Australia
2
Gold Coast University Hospital
Gold Coast, Queensland, Australia
3
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
4
Alfred Hospital
Prahran, Victoria, Australia, 3004