A study to determine if low temperature if started very early after head injury helps to lessen brain damage in patients with severe head injury

Not Applicable

• Conditions: Health Condition 1: null- Severe Traumatic Brain Injury (TBI)

• Registration Number: CTRI/2015/06/005906
• Lead Sponsor: Australian and New Zealand Intensive Care Research Centre ANZIC RC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

Pre hospital and Emergency Department Inclusion Criteria-

• 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 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 scene or in transit

• GCs is 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 Department 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

• Clinically significant bleeding likely to require haemostatic intervention, for example:

o Bleeding into the chest, abdomen or retro-peritoneum likely to require surgery,embolisation

o Pelvic fracture likely to require surgery , embolisation

o More than two long bone fractures requiring operative fixation

• GCS is 3 and un-reactive pupils

• Cardiac arrest at scene or in transit

• 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 clinicianâ??s opinion, cooling is not in the patientâ??s best interest.

Study & Design

• Study Type: Interventional
• Study Design: Not specified