WINTHROP-UNIVERSITY HOSPITAL ANNOUNCING POSSIBLE RESEARCH STUDY FOR EMERGENCY TREATMENT OF TRAUMATIC BRAIN INJURY
In order to comply with federal guidelines, Winthrop-University Hospital Clinical Trials Center and Elzbieta Wirkowski, MD, Director of Cerebrovascular Disorders and Medical Director of Winthrop’s Neurosciences Special Care Unit, have announced that they are considering participation in a clinical research study of an investigational medication that would be administered in the emergency room to patients who have suffered a traumatic brain injury (TBI). As this is considered “emergency research,” federal regulations require that community members are informed about the possibility of the study, and given an opportunity to ask questions or provide feedback.
TBI is a serious injury that can cause long-term problems and even death. The study medication is a hormone called progesterone that is naturally found in the human body. Information suggests that progesterone, when given soon after injury, may help treat brain injuries by reducing brain swelling and damage. The purpose of the study is to find out if the study medicine is safe and if it will reduce the damage from TBI when it is given along with the standard medical care for brain injury.
If eligible for the study, patients will have a 50/50 chance that the study medicine given to them will contain progesterone. Half of the patients in the study will receive treatment with progesterone and half of the patients will not receive progesterone, but will be given a placebo. All other treatments and medical care given for brain injuries will be the same “standard of care” that the hospital administers to TBI patients. Neither the patient nor the study team will know if the patient has received progesterone until the study is finished. However, this information is available to the study physician if needed in an emergency.
The study would be conducted under the guidelines of the U.S. Food and Drug Administration (FDA). The FDA is an agency of the federal government that oversees human research involving medicine. The FDA has allowed a set of special rules, called “Exception from Informed Consent” (EFIC), to guide emergency research. EFIC allows research studies to be done in certain emergency situations.
EFIC applies only when:
- The person’s life is at risk, and
- The standard treatments available may not work, and
- The study might help the person, and
- It is not possible to get permission:
- from the person because of his or her medical problem nor
- from the person’s legally authorized representative because there is a very short amount of time allowed to treat the medical problem.
Under the guidelines of EFIC, once the patient regains consciousness or their authorized representative is reached, that person can either choose to continue or discontinue enrollment in the study.
For information, questions, or comments about this proposed study, please call the Clinical Trials Center at (516) 663-9582 or e-mail email@example.com. # # #