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Table 1 Inclusion and exclusion criteria

From: Statistical analysis plan for the POLAR-RCT: The Prophylactic hypOthermia trial to Lessen trAumatic bRain injury-Randomised Controlled Trial

Pre-hospital inclusion criteria Emergency Department inclusion criteria
 • Blunt trauma with clinical diagnosis of severe TBI and GCS < 9
 • Estimated age ≥ 18 and < 60 years
 • The patient is intubated or intubation is imminent
 • Blunt trauma with clinical diagnosis of severe TBI and GCS < 9
 • Estimated age ≥ 18 and < 60 years
 • The patient is intubated or intubation is imminent
Pre-hospital exclusion criteria Emergency Department exclusion criteria
 • Clinical diagnosis of drug or alcohol intoxication as predominant cause of coma
 • Randomisation unable to be performed within 3 h of estimated time of injury
 • Estimated transport time to study hospital > 2.5 h
 • Able to be intubated without drugs
 • Systolic BP < 90 mmHg
 • Heart rate > 120 bpm
 • Cardiac arrest at the scene or in transit
 • 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
Known to be carer dependent due to a pre-existing neurological condition
 • Clinical diagnosis of drug or alcohol intoxication as predominant cause of coma
 • Randomisation unable to be performed within 3 h of estimated time of injury
 • Able to be intubated without drugs
 • Persistent systolic BP < 90 mmHg
 • 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