Status:
TERMINATED
Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
16-45 years
Phase:
PHASE3
Brief Summary
Induction of hypothermia to \< 35˚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 incr...
Detailed Description
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 moder...
Eligibility Criteria
Inclusion
- Non-penetrating brain injury with post-resuscitation Glasgow Coma Score (GCS) \< 8 (motor 1-5)
- Estimated or known age \> 16 and \< 45 years old
- Time of Injury within 2.5hrs of arrival at hospital
Exclusion
- 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
- GCS = 3 AND bilaterally non-reactive pupils
- Abbreviated Injury Score (AIS) \> 4 for any body area except head
- Positive abdominal ultrasound or CT scan
- Persistent hypotension (systolic blood pressure \< 110mmHGg)
- Persistent hypoxia (O2 Saturation \< 94%)
- Positive pregnancy test
- Injured greater than 2.5 hours from hospital arrival
- Pre-existing medical conditions, if known
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT00178711
Start Date
November 1 2005
End Date
December 1 2009
Last Update
September 17 2014
Active Locations (5)
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1
University of St Louis : St. Louis University Hospital
St Louis, Missouri, United States, 63110
2
University of Pittsburgh : University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
3
University of Texas Health Science Center, Memorial Hermann Hospital
Houston, Texas, United States, 77030
4
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304