Pittsburgh, July 25, 2002 -- Every 15 seconds, a person in the United States sustains a traumatic brain injury, resulting in 1,500,000 new cases of brain injury each year. Of these patients, over 260,000 (17%) will be hospitalized, of which more than 50,000 will die, and 80,000 will be permanently disabled (Division of Acute Care et al., 1999). A sizeable fraction of the patients die, and a large group survive with severe, long-term disabilities. Recognizing the need to optimize the treatment and care of patients with traumatic head injury, studies are being conducted to address this problem (http://www.ninds.nih.gov).

Traumatic brain injury (TBI) is a complex disease. Once the original injury has occurred, it is the job of the medical team to prevent or lessen the spread of secondary damage to the brain. Many physiological processes have been implicated in contributing to brain damage. The interactions among these various physiological events, and the long-term changes over time are still unclear.

The Pittsburgh area, along with 11 other sites across the U.S. will participate in the National Acute Brain Injury Study. The study will be coordinated by the University of Texas and will be conducted locally through the University of Pittsburgh, UPMC Health System. The study will be funded by the National Institute of Health, Department of Health and Human Services; Public Health Serves.

This study will exam randomly selected unconscious victims of a traumatic brain injury. Upon admission to the hospital, the clinical trial will begin immediately in which management at hypothermia (33°C/91.4°F) for 48 hours is tested against standard management at normal body temperature in patients with the ages between 16-45 years, and with admission temperature <= 35°C/95°F. The primary outcome measure will be to examine the difference of the Glasgow Outcome Scale at 6 months after injury (Good Recovery/Moderate Disability vs. Severe Disability/Vegetative/Dead). Two hundred and twenty patients through out the US will be needed to determine the difference.

After screening, but prior to enrollment, informed consent must be obtained or it must be determined that the patient meets the criteria for use of waiver of consent (Federal Register, 1995; Federal Register, 1996).

Many brain-injured patients arrive at the hospital unidentified, without next-of-kin identification, or their families are unavailable. Because the study requires a subject who has a severe head injury, he/she will be unconscious and will require proxy consent from the closest relative. Due to the time restraints of the study, one (1) hour of concerted effort after the patient's hospital arrival and identification will be applied to locating family members. Once the family is notified, he/she will be approached by clinicians who are directly involved in the patient's care, regarding their relative's study participation.

If waiver of consent is used, the family will be informed of the patient's participation in the study as soon as the family arrives. Permission to continue therapy will be obtained as an addendum to the consent form. In the event that permission to continue participation is not given, patients will be slowly re-warmed, if randomized to hypothermia, and withdrawn from the study.

The nature of the study, along with the potential benefits and risks, will be explained to the patient's surrogate decision maker. They will have the right to refuse to take part and/or withdraw from this study at any time without penalty or loss of care. Their ongoing medical care will not be affected by the decision to take part or not take part in this study. Patients who take part in the study will get the same kind of care that is considered the community standard. Patients who do not to take part in the study will receive community standard of care.

We welcome your comments about a "waived consent." Please send an e-mail (BTRC@upmc.edu) with your approval, disapproval or comments for the method of informing the family and obtaining permission for the study.

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E-mail:
BTRC@upmc.edu

Funding for the trial is supported by the Department of Health and Human Services.