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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00178711
Recruitment Status : Terminated (Futility)
First Posted : September 15, 2005
Results First Posted : August 11, 2014
Last Update Posted : September 17, 2014
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Guy Clifton, The University of Texas Health Science Center, Houston

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

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Device: Hypothermia Phase 3

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 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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: National Acute Brain Injury Study: Hypothermia IIR
Study Start Date : November 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: hypothermia
Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 2.5 hours of injury and maintained for 48 hours.
Device: Hypothermia
Induction of moderate hypothermia to 33 degrees celsius, within 2.5 hours from time of injury and maintained for 48 hours
Other Name: moderate hypothermia

No Intervention: control
treated at normothermia

Primary Outcome Measures :
  1. The Dichotomized Glasgow Outcome Scale [ Time Frame: 6 months with a window of plus or minus one month ]
    The primary outcome measure was the Glasgow Outcome Scale measured in person six months after injury by examiners who were blinded to the patient's treatment group. Good recovery and moderate disability were designated as favorable outcomes; severe disability, a vegetative state, and death as poor outcomes.

Other Outcome Measures:
  1. Glasgow Outcome Scale - Extended [ Time Frame: 0-12 months ]
  2. Disability Rating Scale [ Time Frame: assessed 0-12 months ]
  3. Neurobehavioral Rating Scale - Revised [ Time Frame: 0-12 months ]
  4. Neurological Outcome Scale for Traumatic Brain Injury [ Time Frame: 0-12 months ]
  5. Symbol Digit Modalities Test [ Time Frame: 0-12 months ]
  6. Rey Osterrieth Complex Figure [ Time Frame: 0-12 months ]
  7. Verbal Selective Reminding Test Trails B [ Time Frame: 0-12 months ]
  8. Grooved Pegboard [ Time Frame: 0-12 months ]
  9. Controlled Oral Word Association Test [ Time Frame: 0-12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00178711

United States, Missouri
University of St Louis : St. Louis University Hospital
St. Louis, Missouri, United States, 63110
United States, Pennsylvania
University of Pittsburgh : University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
University of Texas Health Science Center, Memorial Hermann Hospital
Houston, Texas, United States, 77030
United States, West Virginia
Charleston Area Medical Center
Charleston, West Virginia, United States, 25304
Canada, Alberta
University of Calgary Health Science Center : Foothills Medical Center
Calgary, Alberta, Canada, T2N4N1
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Guy L Clifton, MD UTHSC-H

Publications of Results:
Responsible Party: Guy Clifton, Professor - Neurosurgery, The University of Texas Health Science Center, Houston Identifier: NCT00178711     History of Changes
Other Study ID Numbers: 5U01NS043353-06 ( U.S. NIH Grant/Contract )
FDA-2014-109 ( Other Identifier: FDA )
First Posted: September 15, 2005    Key Record Dates
Results First Posted: August 11, 2014
Last Update Posted: September 17, 2014
Last Verified: September 2014

Keywords provided by Guy Clifton, The University of Texas Health Science Center, Houston:
Traumatic Brain Injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Body Temperature Changes
Signs and Symptoms