The prophylactic hypothermia trial to lessen traumatic brain injury – randomised controlled trial.

Not Applicable

Recruiting

• Conditions: Severe traumatic brain injury; Neurological - Other neurological disorders; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12609000764235
• Lead Sponsor: Australian and New Zealand Intensive Care-Research Centre, Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 500

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
Known or obvious pregnancy
Receiving hospital is not a study site
Evidence of current anti-coagulant treatment
Known to be carer dependent due to a pre-existing neurological condition

***********Emergency Dept 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
Able to be intubated without drugs
Persistent Systolic BP <90mmHg
GCS=3 + un-reactive pupils
Cardiac arrest at the scene or in transit
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
Known to be carer dependent due to a pre-existing neurological condition
In the treating clinician’s opinion, cooling” is not in the patient’s best interest

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of favourable neurological outcomes (Glasgow Outcome Score Extended: GOSE 5 to 8)[6 months post injury]