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TUH TO LEAD NATIONAL BRAIN INJURY STUDY
February 19, 2010
CONTACT: Renee Cree, firstname.lastname@example.org
Temple University Hospital will serve as the regional hub for a new, nationwide study called ProTECT III, coordinating the efforts of three Level-I trauma centers in Philadelphia — Hahnemann, Thomas Jefferson, and Temple— as well as Penn State–Hershey Medical Center and Geisinger Medical Center in Danville, Pa., to determine whether the use of progesterone will help stave off permanent brain damage in patients with traumatic brain injury (TBI).
In a recent pilot study of patients with TBI, those on progesterone had a death rate of just 13 percent from their head injuries, less than half the death rate of those on standard treatment, with no negative side effects.
The study, known as ProTECT III, will seek to confirm these findings with a national pool of patients.
Each TBI patient that comes into the emergency room will be given the current standard of care for brain injury — controlling blood pressure and oxygen levels— and might undergo surgery to try and limit the amount of damage to the brain.
At ProTECT study hospitals, the patient will also be randomly assigned a placebo or the progesterone for four days. After treatment, all subjects will have follow up calls and visits with study team members to track their progress.
Because optimal treatment within the first four hours of TBI is crucial to successful to recovery, the Federal Drug Administration has deemed an exception from informed consent (EFIC) for this study.
Sites involved in the study will try to contact the patient’s relatives for one hour; if they can’t be reached, the patient will be started on the medication while efforts to reach a relative or their legally authorized representative continues throughout the duration of the study.
Anyone who declines in advance to participate will be identified by searching a ProTECT opt-out electronic database or by a bracelet, provided by each site, and will not be given the medication if admitted to the emergency room with a TBI.
“If this study proves that using progesterone in traumatic brain injury cases works, this would be the most promising breakthrough in improving outcomes for traumatic brain injury patients,” said Nina Gentile, a Professor of Emergency Medicine at the School of Medicine, and head of the study’s regional efforts. “It is awesome to me that it is the naturally produced hormone progesterone that might rescue brain cells.”
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