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


Condition Intervention Phase
Traumatic Brain Injury
Procedure: 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 (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 ]

Estimated Enrollment: 240
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 4 hours of injury and maintained for 48 hours.
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
No Intervention: control

Detailed Description:

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).

  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

No publications provided by The University of Texas Health Science Center, Houston

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Guy L. Clifton M.D., UTHSC Department of Neurosurgery
ClinicalTrials.gov Identifier: NCT00178711     History of Changes
Other Study ID Numbers: S U01 NS043353-02, Grant# 5 U01 NS043353-05
Study First Received: September 13, 2005
Last Updated: April 12, 2010
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:
Hypothermia
Brain Injuries
Wounds and Injuries
Body Temperature Changes
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 24, 2014