ACTRN12609000764235
Recruiting
未知
Multi-centre randomised trial to evaluate the effect of early hypothermia on neurological function in patients with severe traumatic brain injury.
Australian and New Zealand Intensive Care-Research Centre, Monash University0 sites500 target enrollmentSeptember 3, 2009
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Severe traumatic brain injury
- Sponsor
- Australian and New Zealand Intensive Care-Research Centre, Monash University
- Enrollment
- 500
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pre\-hospital Inclusion Criteria
- •\*Blunt trauma with clinical diagnosis of severe Traumatic Brain Injury (TBI) and Glasgow Coma Scale \<9
- •\*Estimated age \= 18 and \< 60 years of age
- •\*The patient is intubated or intubation is imminent
- •Emergency Dept Inclusion Criteria
- •\*Blunt trauma with clinical diagnosis of severe TBI and GCS \<9
- •\*Estimated age \> or \= 18 and \< 60 years of age
- •\*The patient is intubated or intubation is imminent
Exclusion Criteria
- •\*\*\*\*\*\*\*\*\*\*\*Pre\-hospital Exclusion Criteria
- •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
- •Cardiac arrest at the scene or in transit
- •GCS\=3 and un\-reactive pupils
- •Penetrating neck/torso injury
Outcomes
Primary Outcomes
Not specified
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