Induction of hypothermia to <35.5˚C by <2.5 hours after severe traumatic brain injury, reaching 33˚C by 4 hours after injury and maintained for 48 hours in patients aged 16-45 will result in an increased number of patients with good outcomes at six months and 12 months after injury compared to patients randomized to normothermia.

Condition	Intervention	Phase
Traumatic Brain Injury	Procedure: Hypothermia	Phase III

Further Study Details: 

Primary Outcomes: The primary outcome measure for the 48-hour moderate hypothermia protocol will be the dichotomized Glasgow Outcome Scale measured by blinded assessment of patients at six months post-injury.
Expected Total Enrollment:  240

NABIS:H IIR is a randomized clinical trial conducted in patients with severe brain injury, age 16-45. Patients will be randomized to standard treatment at normothermia or to standard treatment with moderate hypothermia (32.5-34C for 48 hours). An intent to treat analysis is 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).

Ages Eligible for Study:  16 Years   -   45 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

1. Non-penetrating brain injury with post-resuscitation GCS < 8 (motor 1-2)
2. Estimated or known age > 16 and < 45 years
3. core temperature < 35.5oC by , 2.5 hours from time of injury

Exclusion Criteria:

1. GCS = 7 or 8 with a normal head CT scan or showing only mild SAH or skull fracture
2. GCS = 3 AND bilaterally non-reactive pupils
3. 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. Estimated or know age > 45 or < 16 years.
8. Positive pregnancy test
9. Core temperature > 35.5oC @ > 2.5 hours form time of injury
10. Pre-existing medical conditions, if known.

Please refer to this study by ClinicalTrials.gov identifier  NCT00178711

Guy L Clifton, MD      713-500-6135    guy.l.clifton@uth.tmc.edu
Melisa Frisby, RN      713-500-6131    melisa.frisby@uth.tmc.edu

Study chairs or principal investigators

Guy L Clifton, MD,  Principal Investigator,  UTHSC-H   

Study ID Numbers:  S U01 NS043353-02
Last Updated:  September 14, 2005
Record first received:  September 13, 2005
ClinicalTrials.gov Identifier:  NCT00178711
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-20