Memphis, Tenn. (December 20, 2010) – The University of Tennessee Health Science Center (UTHSC) and the Elvis Presley Memorial Trauma Center (located in the Regional Medical Center at Memphis) have been selected to participate in a national study sponsored by the National Institutes of Health. The study will examine treatment for traumatic brain injury (TBI). TBI is the leading cause of death and disability in children and adults ages 1 to 44. The study, referred to as ProTECT III, involves treating victims who are at least 18 years of age and have experienced a TBI resulting from blunt trauma. ProTECT III is scheduled to begin during the first quarter of 2011 for adult patients entering the Trauma Center with TBI cases.
Every 15 seconds, someone in our nation suffers from a major TBI. ProTECT III is designed to determine if progesterone (a hormone normally found in our bodies) can reduce the amount of brain damage caused by traumatic brain injury. Recent studies suggest that progesterone, administered immediately after a TBI, may help by reducing brain swelling and damage. The study is led locally by Martin A. Croce, MD, UTHSC professor of Surgery, chief of the UTHSC College of Medicine Division of Trauma and Critical Care, and medical director for the Elvis Presley Memorial Trauma Center.
"Despite the enormity of the problem, there is no effective medication currently approved by the FDA to improve the outcome of TBI and treatment has not advanced much in the past 30 years," said Dr. Croce. He added, "According to data from small studies already completed, we are encouraged that the administration of progesterone could be a major advancement in the treatment of patients with TBI."
While researchers normally obtain permission (consent) before a person is included in a research study, an individual suffering from a TBI will not be able to give consent at the time of injury. A TBI must be treated quickly. Thus, there may not be enough time to locate and speak with an injured person's guardian about the patient participating in the study. In this situation, individuals may be enrolled in the study without his/her legal guardian's consent. This is referred to as "Exception from Informed Consent" and is allowed by the U.S. Food and Drug Administration in certain circumstances when specific criteria are met. Once the legal guardian is located, he/she will be provided study information and asked to either give permission allowing the injured person to continue in the study or to end study participation.
For more information on the study, including how to avoid future enrollment, call 901-448-4488 or e-mail questions to firstname.lastname@example.org, or visit the study Web site at www.protectiii.com where you can voice your opinion about ProTECT III by completing the online survey.