PITTSBURGH – May 17, 2007 – A renowned Children's Hospital of Pittsburgh of UPMC neurosurgeon will lead a $11.5 million National Institutes of Health-funded clinical trial examining the effectiveness of induced hypothermia as a therapy for brain swelling in children who have suffered traumatic brain injuries.
P. David Adelson, MD, director of the Pediatric Neurotrauma Center at Children's and the A. Leland Albright Professor of Neurosurgery at the University of Pittsburgh School of Medicine, will lead researchers at 12 sites throughout the country.
Researchers plan to enroll 340 children up to age 16 in the five-year, Phase III randomized trial, which is being funded by the National Institute of Neurological Disorders and Stroke. In Pittsburgh, Children's will serve as the clinical site for the study and Pitt will serve as the coordinating site.
A previous Phase II clinical trial of induced hypothermia therapy led by Dr. Adelson at Children's found that moderate hypothermia therapy is safe and may potentially improve outcome. Results of that study were published in the journal Neurosurgery in April 2005.
"We've proven this therapy is safe. Now if we can determine that it is effective, it would be a major breakthrough because currently there are very limited treatments that improve outcome following traumatic brain injury in children," Dr. Adelson said. "The belief is that cooling impacts the cascade of events that leads to brain swelling. Reducing brain swelling potentially could prevent further injury."
Patients in the study selected to receive hypothermia therapy will be cooled to between 32–33 degrees Celsius (89–90 degrees Fahrenheit), using special cooling blankets and/or cooled saline injected intravenously. They will be cooled for 48 hours and then followed by researchers for one year to track outcomes, with a battery of tests being conducted at six and 12 months following injury.
According to federal law and Pitt policy, those who participate in a clinical research study must provide or, in the case of a child, have a guardian provide informed consent. Because of the nature of this trial and the fact that hypothermia must be induced within six hours of injury, it may be impossible to obtain consent at the time of brain injury. For this reason, researchers are notifying the public that informed consent will be waived. Researchers will make every attempt to contact family members to provide notification and obtain consent for continued participation as soon as possible after enrollment.
Some of the other major centers participating in the trial are: University of California, Davis Medical Center (University of California Davis); Miami Children's Hospital and Jackson Memorial Hospital (University of Miami); Children's Medical Center of Dallas (University of Texas Southwestern Medical Center); Penn State Milton S. Hershey Medical Center (Penn State University); Johns Hopkins University Hospital, Duke University, Long Island University, Semmes Murphy Clinic (University of Tennessee), and Harborview Medical Center (University of Washington).
For more information about Dr. Adelson's pediatric traumatic brain injury and induced hypothermia research or about Children's Division of Pediatric Neurosurgery, please visit www.chp.edu.