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| Sponsored by: |
National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
| ClinicalTrials.gov Identifier: | NCT00040339 |
Purpose
The purpose of this trial is to determine if hypothermia (body cooling), administered very soon after a severe brain injury improves functional outcome.
This pilot trial ended in July 2005. Please see clinicaltrials.gov record number NCT00178711 for the Phase III version of the trial (see link below).
| Condition | Intervention |
|---|---|
|
Brain Injuries Hypothermia |
Procedure: hypothermia (body temperature lowered to 33°C or 91.4°F) |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized |
| Official Title: | The National Acute Brain Injury Study: Hypothermia II (NABISH II) |
| Estimated Enrollment: | 42 |
| Study Start Date: | May 2002 |
| Study Completion Date: | July 2005 |
After brain injury, the brain produces certain chemicals that are harmful to the injured tissues. Moderate hypothermia—also called body cooling—may slow or prevent the production of these chemicals. Hypothermia also decreases the amount of oxygen needed by the brain, which may provide some protection during this critical period. Earlier studies have shown that maintenance of moderate hypothermia may have a helpful effect in head injury patients ages 16 to 45 who arrive at the hospital with a low body temperature suggesting that very early cooling may be beneficial.
In this study scientists will initiate hypothermia or body cooling to 35˚C within two hours of severe brain injury to determine if body cooling improves functional outcome.
Patients may enter the study in one of two ways. They may be evaluated and surface cooling begun at the scene by emergency medical services (EMS) personnel affiliated with the study; or patients who arrive in the emergency department (ED) of the study hospital within 2 hours of injury—and who have not already been evaluated by EMS personnel affiliated with the study—will be evaluated and cooling begun, if applicable, by NABISH study personnel.
NABISH-trained EMS personnel who reach a patient with a suspected severe head injury within 2 hours of injury will induce hypothermia to 35˚C at the scene, in transit, or in the ED.
NABISH study personnel will induce hypothermia to 35˚C in the ED in patients with suspected severe head injury who reach the ED within 2 hours of injury if cooling has not already begun. Patients who meet entry criteria (based upon past studies) for moderate hypothermia for 48 hours will then be cooled to 33˚C and then gradually rewarmed after 48 hours at 33˚C. Patients initially cooled to 35˚C within 2 hours of injury who prove during trauma evaluation to have exclusion criteria for 48 hours of moderate hypothermia will be warmed from 35˚C to 37˚C.
This pilot trial ended in July 2005. Please see clinicaltrials.gov record number NCT00178711 for the Phase III version of the trial (see link below).
Eligibility| Ages Eligible for Study: | 16 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
ELIGIBILITY CRITERIA FOR EARLY COOLING TO 35°C:
Inclusion Criteria:
Exclusion Criteria:
ELIGIBILITY CRITERIA FOR 48 HOURS OF MODERATE HYPOTHERMIA (33°C):
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Missouri | |
| St. Louis University | |
| St. Louis, Missouri, United States, 63103 | |
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45221 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15260 | |
| United States, Texas | |
| University of Texas-Houston | |
| Houston, Texas, United States, 77030 | |
| Canada, Alberta | |
| University of Calgary | |
| Calgary, Alberta, Canada, T2N 1N4 | |
| Principal Investigator: | Guy L. Clifton, M.D. | Professor and Chair, Department of Neurosurgery, University of Texas-Houston, Houston Medical Center |
More Information
| Study ID Numbers: | R01NS43353 |
| Study First Received: | June 24, 2002 |
| Last Updated: | December 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00040339 History of Changes |
| Health Authority: | United States: Federal Government |
|
brain injury hypothermia body cooling body temperature body cooling |
|
Craniocerebral Trauma Signs and Symptoms Hypothermia Wounds and Injuries Disorders of Environmental Origin |
Central Nervous System Diseases Trauma, Nervous System Brain Diseases Brain Injuries |
|
Craniocerebral Trauma Signs and Symptoms Hypothermia Nervous System Diseases Wounds and Injuries Disorders of Environmental Origin |
Central Nervous System Diseases Trauma, Nervous System Body Temperature Changes Brain Diseases Brain Injuries |
