GMC to participate in ProTECT III study of progesterone for emergency treatment of TBI

Geisinger Medical Center (GMC) will participate in ProTECT III, a groundbreaking National Institute of Health (NIH)-sponsored research study for the emergency treatment of traumatic brain injuries (TBI) using the hormone progesterone.

"By participating in the ProTECT III national study, we have the exciting opportunity to be part of the discovery process for improving outcomes in patients suffering from traumatic brain injuries," said Steven A. Toms, M.D., MPH, FACS, Director of Neurosurgery for Geisinger Health System. "It has been more than 30 years since new pharmacological therapies have been introduced for TBIs, but this study will determine the efficacy of administering intravenous progesterone when treating victims of moderate to acute TBI."

Progesterone is a hormone naturally present in small but measurable amounts in everyone's body.

"Studies suggest that progesterone exerts protective effects on damaged brain tissue, and if the results of this clinical trial mirror those of previous studies, progesterone could be a major breakthrough and help save many lives," Dr Toms said.

Approximately two million Americans suffer from TBIs every year, causing 50,000 deaths and 80,000 new cases of long-term disability, according to the Centers for Disease Control and Prevention. Despite the enormity of the problem, scientists have failed to identify effective medications to improve outcomes following a TBI, Dr. Toms said.

In previous phases of the ProTECT trial, mortality rates decreased by 50 percent for TBI patients treated with the hormone. While these previous trials were smaller pilot studies, researchers involved with ProTECT III hope to confirm their preliminary findings.

The ProTECT III trial is being conducted at 17 major trauma centers across 15 states nationwide and will include 1140 patients. Other medical centers participating in Pennsylvania include Hershey Medical Center, Temple University Medical Center, Jefferson Medical Center and Drexel University Medical Center. The lead study site is Emory University School of Medicine in Atlanta, Ga.

As part of the trial, patients may be enrolled in the study without consent because the effectiveness of the hormone is highly dependent on being administered to the patient as quickly as possible after sustaining a brain injury.

The U.S. Food and Drug Administration (FDA) has allowed a set of special rules called "Exception from Informed Consent" (EFIC), allowing research studies to be conducted in certain emergency situations without consent. The rules apply when the patient is in a life-threatening situation, current treatments are unproven or unsatisfactory, the study may provide direct benefit to the patient and it is impossible to receive consent from the patient due to their condition or from their legal guardian because there is a limited amount of time to start the study medicine.

The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury. A placebo looks the same as progesterone but does not have any drug in it.

"Patients will be entered into this study throughout a period of 3 years as long as they fit certain criteria, such as age, type of injury and the time between suffering the injury and the start of the investigational treatment," said Dr. Toms. "Family members and next-of-kin will be completely informed about the research study as soon as possible and can choose to keep the patient in the study or remove them from it."

The duration of the study is five years, and will involve Geisinger physicians in neurosurgery, trauma, the emergency department, critical care and psychiatry. Participating patients will remain in the study from trial entry until six months post-injury. Should you wish to be excluded from the possibility of participating in this study, please call 1-866-766-3475. For more information about this study, please call Project Manager Kristina Evans, M.P.H., at 570-214-9553 or visit the web at survey.geisinger.org/protect.

"This study represents an opportunity to be a part of a major advancement in the treatment of TBIs," Dr. Toms said. "Our hope is that we can contribute to a greater understanding of how to approach TBIs and to improve patient outcomes."