Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury (NABIS:HIIR)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178711
First received: September 13, 2005
Last updated: April 12, 2010
Last verified: April 2010

September 13, 2005
April 12, 2010
November 2005
December 2009   (final data collection date for primary outcome measure)
The dichotomized Glasgow Outcome Scale (Good Recovery/Moderate Disability vs. Severe Disability/Vegetative/Dead) [ Time Frame: 6 months with a window of plus or minus one month ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00178711 on ClinicalTrials.gov Archive Site
Not Provided
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Effects of Hypothermia Upon Outcomes After Acute Traumatic Brain Injury
National Acute Brain Injury Study: Hypothermia IIR

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 and 12 months after injury compared to patients randomized to normothermia.

NABIS:HIIR 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).

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Traumatic Brain Injury
Procedure: Hypothermia
Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours
Other Name: moderate hypothermia
  • Active Comparator: hypothermia
    Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours.
    Intervention: Procedure: Hypothermia
  • No Intervention: control

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
16 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00178711
S U01 NS043353-02, Grant# 5 U01 NS043353-05
Yes
Guy L. Clifton M.D., UTHSC Department of Neurosurgery
The University of Texas Health Science Center, Houston
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Guy L Clifton, MD UTHSC-H
The University of Texas Health Science Center, Houston
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP