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

This study has been terminated.
(Futility)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Guy Clifton, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00178711
First received: September 13, 2005
Last updated: September 13, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Traumatic Brain Injury
Device: Hypothermia
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: National Acute Brain Injury Study: Hypothermia IIR

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • The Dichotomized Glasgow Outcome Scale [ Time Frame: 6 months with a window of plus or minus one month ] [ Designated as safety issue: No ]
    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:
  • Glasgow Outcome Scale - Extended [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Disability Rating Scale [ Time Frame: assessed 0-12 months ] [ Designated as safety issue: No ]
  • Neurobehavioral Rating Scale - Revised [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Neurological Outcome Scale for Traumatic Brain Injury [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Symbol Digit Modalities Test [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Rey Osterrieth Complex Figure [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Verbal Selective Reminding Test Trails B [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Grooved Pegboard [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]
  • Controlled Oral Word Association Test [ Time Frame: 0-12 months ] [ Designated as safety issue: No ]

Enrollment: 232
Study Start Date: November 2005
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178711

Locations
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
Investigators
Principal Investigator: Guy L Clifton, MD UTHSC-H
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guy Clifton, Professor - Neurosurgery, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00178711     History of Changes
Other Study ID Numbers: 5U01 NS043353-06, FDA-2014-109
Study First Received: September 13, 2005
Results First Received: July 31, 2014
Last Updated: September 13, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 19, 2014