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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