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Home > "H" Clinical Trials Conditions > Hypothermia to Treat Severe Brain Injury  Hypothermia to Treat Severe Brain Injury
Hypothermia to Treat Severe Brain Injury
For Condition: Brain Injuries,Hypothermia
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: The purpose of this trial is to determine if hypothermia (body cooling), administered very soon after a severe brain injury in patients who are hypothermic on admission, improves functional outcome.
Details: 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 (less than 35 degrees Celsius [35°C] or 95 degrees Fahrenheit [95°F]). The purpose of this study is to compare the outcome for patients with severe brain injuries who are hypothermic on admission (<35°C) and who receive standard care (passive rewarming) with the outcome for patients who receive 48 hours of moderate hypothermia (body temperature lowered to 33 degrees Celsius [33°C] or 91.4 degrees Fahrenheit [91.4°F]) started as soon as possible after injury.
Eligibility:
Study Type: Interventional, Treatment, Randomized
Minimum Age/Maximum Age: 16 Years/45 Years
Genders: Both
Protocol Entry Criteria: INCLUSION Criteria: - Non-penetrating brain injury with a post-resuscitation Glasgow Coma Score < 8 (motor 1-5). - Body temperature on admission to the Emergency Department < 35.0°C (bladder or rectal temperature). - Arrival at a study center and available for cooling within four hours of injury. - Negative pregnancy test for female subjects. EXCLUSION Criteria: - Glasgow Coma Score = 7 or 8 with a normal CT scan or a CT scan showing only mild subarachnoid hemorrhage or skull fracture. - Glasgow Coma Score = 3 and bilaterally unreactive pupils. - Body temperature on admission to the Emergency Department > 35.0°C (bladder or rectal temperature). - Persistent hypotension in the Emergency Department (systolic blood pressure < 90 mmHg for > 30 minutes after arrival). - Persistent hypoxia in the Emergency Department (arterial oxygen saturation < 94% for > 30 minutes after arrival). - Abbreviated Injury Score > 4 for any body area other than head. - Unavailable for cooling within four hours of injury. - Unlikely to complete follow-up procedures.
Total Enrollment: 220
Location and Contact Information:
Overall Study Official:
GuyClifton, Principal Investigator, Professor and Chair, Department of Neurosurgery, Vivian L. Smith Center for Neurological Research, University of Texas-Houston, Houston Medical Center
University of Texas-Houston *Recruiting*
Houston, Texas, 77030
United States
Recruiting
University of California - Davis *Recruiting*
Sacramento, California, 95616
United States
Recruiting
University of Pittsburgh *Not yet recruiting*
Pittsburgh, Pennsylvania, 15260
United States
Not yet recruiting
University of Mississippi *Not yet recruiting*
Jackson, Mississippi, 38677
United States
Not yet recruiting
Fairfax/INOVA Hospital *Not yet recruiting*
Fairfax, Virginia, 22042
United States
Not yet recruiting
St. Louis University *Recruiting*
St. Louis, Missouri, 63103
United States
Recruiting
University of San Francisco *Not yet recruiting*
San Francisco, California, 94117
United States
Not yet recruiting
Duke University *Not yet recruiting*
Durham, North Carolina, 27708
United States
Not yet recruiting
University of Southern California *Recruiting*
Los Angeles, California, 90089
United States
Recruiting
Additional Information:
Study ID Numbers: R01NS43353;
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040339
Other Hypothermia Studies:
1. Hypothermia to Treat Severe Brain Injury
2. Hypothermia During Intracranial Aneurysm Surgery Trial
Related Studies:
Other Hypothermia Clinical Trials
Other Virginia Clinical Trials
Other Fairfax Clinical Trials
Hypothermia to Treat Severe Brain Injury
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