NABIS:HIIR was a randomized clinical trial conducted in patients with severe brain injury, age 16-45. Patients were randomized to standard treatment at normothermia or to standard treatment with moderate hypothermia (32.5-34C for 48 hours). An intent to treat analysis was used with the primary outcome measure as the Glasgow Outcome Scale at six months after injury. GOS is dichotomized into good outcome (Good Recovery/Moderate Disability) and poor outcome (Severe Disability, Vegetative, Dead).
Inclusion Criteria: 1. Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) < 8 (motor 1-5) 2. Estimated or known age > 16 and < 45 years old 3. Time of Injury within 2.5hrs of arrival at hospital Exclusion Criteria: 1. GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoid hemorrhage (SAH)or skull fracture or GCS > 9 post- randomization 2. GCS = 3 AND bilaterally non-reactive pupils 3. Abbreviated Injury Score (AIS) > 4 for any body area except head 4. Positive abdominal ultrasound or CT scan 5. Persistent hypotension (systolic blood pressure < 110mmHGg) 6. Persistent hypoxia (O2 Saturation < 94%) 7. Positive pregnancy test 8. Injured greater than 2.5 hours from hospital arrival 9. Pre-existing medical conditions, if known