May 21 , 2003
FOR IMMEDIATE RELEASE

CONTACT: Tom Rosenberger, APR, Communications Department (513) 569-5260
CONTACT: Cindy Starr, MSJ, Communications Department (513) 584-2214

CINCINNATI -- The University of Cincinnati Department of Neurosurgery is seeking public input before it launches federally funded research aimed at improving the odds that patients who suffer severe traumatic brain injury will go on to live a normal life.

The randomized clinical trial will assess whether maintaining a moderately low body temperature - or hypothermia -- in patients with severe traumatic brain injury will improve their mental and physical outcomes. Raj K. Narayan, M.D., chairman of the Department of Neurosurgery and a neurosurgeon with the Mayfield Clinic & Spine Institute, will lead the Cincinnati portion of the study.

"There is a great need to find treatments that improve outcome," said Dr. Narayan, an internationally recognized trauma expert. "A previous hypothermia study for this treatment appeared to be effective for a subgroup of patients. This study will examine hypothermia more closely in that particular subgroup."

Public comment is required before the study begins because researchers will in some cases be forced to proceed with treatment without having acquired consent. Patients suffering severe head injuries are unconscious and unable to provide their consent to become part of a research trial. A relative or guardian, meanwhile, may not be immediately available to grant consent in their behalf.

Roughly 1.5 million Americans suffer a traumatic brain injury each year. About 50,000 die and another 80,000 are permanently disabled. About 30 percent of patients with brain injuries are hypothermic upon arrival at the hospital, often because of cold weather, intoxication, small body type, or cold intravenous fluids that have been administered by paramedics at the accident site.

Results of the first National Acute Brain Injury Study, Hypothermia I, found that in patients aged 16-45, maintaining hypothermia after a severe head injury led to improved outcome. Forty-eight percent of patients who were kept cold for a period of time had a good outcome and were able to live independently. By contrast, only 24 percent of the hypothermic patients who were re-warmed had a significant recovery. The results of the five-year study were published in the February 2001 New England Journal of Medicine.

The benefits received from hypothermia treatment are not completely understood. Scientists have reported that lower temperatures stabilize the flow of blood and inhibit the release of toxic brain chemicals that cause secondary injuries after the initial traumatic injury.

The current study, the National Acute Brain Injury Study, Hypothermia II, involves patients aged 16-45 who have suffered a closed traumatic brain injury and are unconscious and already hypothermic when brought to the hospital. A qualifying patient will be randomly assigned to one of two groups. One group will receive hypothermic treatment, which involves keeping the body temperature cool (91.4 degrees Fahrenheit) for 48 hours. The other group will receive standard treatment, which involves warming the body to a normal temperature (98.6 degrees Fahrenheit). The nationwide study, funded by the National Institutes of Health, will take place in nine sites and is expected to enroll 220 patients over four years. The UC team expects to enroll approximately 20 to 25 patients over the four-year period at The University Hospital.

Federal law established the "waiver of consent" in 1996 so that physicians could begin emergency experimental treatment after any injury before obtaining consent from the patient or from a legal guardian or family member. Under terms of the hypothermia study, if a hospital is unable to reach a family member after 60 minutes of diligent effort, the neurosurgical team is allowed to enroll patients who meet the study's stringent criteria.

To qualify for the waiver, researchers must first explain the research to the community and gather feedback. UC researchers will discuss the hypothermia trial at community meetings during the next several weeks, with particular emphasis on demographic groups known to have a statistically elevated risk of severe traumatic brain injury. In addition, UC researchers must assess local residents' willingness to accept the experimental treatment. A complete description of the study can be reviewed on our clinical trials website at www.mayfieldclinic.com/ClinicalTrials.htm. We invite those who review the study description to take a moment to complete a short accompanying survey.

For more information, please contact Suzanne Kempisty-Cliver, RN, at (513) 558-3590 or clinicaltrials@mayfieldclinic.com