Penn State Hershey begins enrolling patient in ProTect Study

February 02, 2011

Penn State Milton S. Hershey Medical Center has begun enrolling patients in a national research study evaluating the use of a hormone during a traumatic brain injury.

Traumatic brain injury is sudden damage to the brain caused by an outside force, such as an automobile accident or a fall. People in south central Pennsylvania who suffer a head injury are most likely to be treated at Penn State Hershey Medical Center, the region's only Level I trauma center. Because the patients eligible for this study are unable to provide informed consent before receiving the study medication, this study will be conducted under federal regulations (21 CFR 50.24) that allow for clinical research in emergency settings using an exception from the requirement for informed consent.

Progesterone for the Treatment of Traumatic Brain Injury, or ProTECT, is studying the use of progesterone, a steroidal hormone found naturally in the body, to limit the damage caused during brain injury. There is currently no drug treatment for traumatic brain injury; instead doctors attempt to control blood pressure and oxygen levels to minimize damage.

Patients 18 years of age and older with a blunt, closed head injury, with moderate to severe brain injury, and who can receive the study medication within four hours from the time of injury, are eligible for this study. Upon arrival at the hospital, patients will be randomly entered into the study, receiving either an IV mixture that includes progesterone or one that does does not (called a placebo). Both sets of patients will receive standard medical care for a brain injury.

Patients under 18 years of age, with a known allergy to eggs, with breast cancer or other cancers of the female organs, who are pregnant, or who are prisoners or in police custody are not eligible for this study.

Participation in the study includes receiving the study medication or placebo, blood tests, receiving calls once per month for five months, and a clinic visit the sixth month to take a series of paper and pencil tests.

Use of the exception from informed consent provision in a study protocol is granted by the Institutional Review Board (IRB) responsible for the initial and continuing review and approval of the research study. Such a decision is based on the finding and documentation that, among other things, patients are in a life-threatening situation requiring emergency medical intervention, currently available treatments are unproven or unsatisfactory, obtaining informed consent is not feasible, potential risks are reasonable in relation to what is known of the condition, participation in the study could provide a direct benefit to the patients enrolled, and the research could not be practicably conducted without an exception from informed consent requirements.

Upon arrival at the Medical Center, study team members will try to locate a legally-authorized representative for one hour to get permission to enter the patient into the study. If a representative cannot be located, study medication or placebo will be started after one hour. Once located, if the representative does not give permission, the study medicine no longer be administered to the patient.

Residents who do not want to participate may visit www.pennstatehershey.org/emergencymedicine, e-mail PROTECT@hmc.psu.edu or call 717-531-1707 option 6 for information on how to be excluded from this study. In addition, residents can add their names to a national opt-out database at www.protectiii.com.

Penn State Hershey Medical Center is one of several academic medical centers nationwide participating in this study. Other hospitals include Temple University, New York Presbyterian Hospital, Stanford University Medical Center and University of Texas Medical Center at Houston, along with others. Lead investigators of this study are Thomas Terndrup, Michelle Fischer, James Leaming (Emergency Medicine); Heidi Frankel (Surgery-Trauma); Christopher Zacko (Neurosurgery); and Claire Flaherty (Neurology).

(Media Contacts)

Last Updated February 02, 2011