Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury

Last updated: September 13, 2014
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Terminated

Phase

3

Condition

Neurologic Disorders

Traumatic Brain Injury

Memory Loss

Treatment

N/A

Clinical Study ID

NCT00178711
5U01NS043353-06
FDA-2014-109
  • Ages 16-45
  • All Genders

Study 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 increased number of patients with good outcomes at six months after injury compared to patients randomized to normothermia.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. GCS = 7 or 8 with a normal head Cat Scan (CT) scan or showing only mild Subarachnoidhemorrhage (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

Study Design

Total Participants: 232
Study Start date:
November 01, 2005
Estimated Completion Date:
December 31, 2009

Study 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 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).

Connect with a study center

  • University of Calgary Health Science Center : Foothills Medical Center

    Calgary, Alberta T2N4N1
    Canada

    Site Not Available

  • University of St Louis : St. Louis University Hospital

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • University of Pittsburgh : University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • University of Texas Health Science Center, Memorial Hermann Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • Charleston Area Medical Center

    Charleston, West Virginia 25304
    United States

    Site Not Available

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