Health Condition 1: null- Severe Traumatic Brain Injury (TBI)
Conditions
Interventions
Intervention1: Early Hypothermia, Controlled group: Early Hypothermia (33 C - 35 C for 72 hours) within 3 hours of injury
Control Intervention1: Standard of care: Standard of care for medical/surgical
Sponsors
Australian and New Zealand Intensive Care Research Centre ANZIC RC
Eligibility
Inclusion criteria
Inclusion criteria: Pre hospital and Emergency Department Inclusion Criteria- • Blunt trauma with clinical diagnosis of severe TBI and GCS • Estimated age >= 18 and • The patient is intubated or intubation is imminent
Exclusion criteria
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 • 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 • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of favourable neurological outcomes (Glasgow Outcome Score Extended: GOSE 5 to 8) at six months following injuryTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Probability of an equal or greater GOSE level at 6 months compared to the probability of a lesser GOSE level, using a proportional odds model â?¢ Probability of an equal or greater GOSE level at 6 months compared to the probability of a lesser GOSE level,using the â??sliding dichotomyâ?? method â?¢ Quality of life assessments (QOL) o EQ5D o SF12 â?¢ Mortality at o six months o hospital discharge Timepoint: AT discharge and 6 months | — |
Countries
Australia, France, India, New Zealand
Contacts
Public ContactDr Deepak Kumar Gupta
Department od Neurosurgery,AIIMS,New Delhi
Outcome results
None listed