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Rhode Island Hospital Will Join National Research Study on Promising Treatment for Traumatic Brain Injury

6/10/2013

Study requires Exception from Informed Consent (EFIC) due to eligible participants’ level of injury


Brain CellRhode Island Hospital is joining a national research study to assess the treatment of traumatic brain injury (TBI) with the naturally occurring hormone progesterone. The multi-site study, ProTECTIII, is funded by the National Institutes of Health and will be led locally by Lisa Merck, MD, MPH, of the department of emergency medicine. It is currently being conducted at 36 sites around the country.

TBI, which is caused by sudden damage to the brain from an outside force to the head, such as that sustained in a car crash or fall, is a significant public health concern. Nearly 2 million adults and children in the U.S. sustain traumatic brain injuries each year resulting in approximately 50,000 deaths, and nearly 80,000 of those affected will require specialized care for the rest of their lives due to resulting disabilities.

“Traumatic brain injury has a profound and devastating effect on our patients,” Merck said. “Prior studies on progesterone indicate that this naturally occurring hormone may serve to protect the brain following such an injury. The ProTECTIII clinical trial will help determine if progesterone, plus standard medical therapy, improves patient outcomes over standard medical therapy alone.”

There are currently no effective drug treatments identified for TBI. However, preliminary research into the use of progesterone from the study’s lead researchers at Emory University in Atlanta, Ga., demonstrates that administering this naturally occurring hormone shortly after brain injury appears safe, and may reduce the risk of death and disability.

Patients with traumatic brain injury are often unconscious or in critical condition, and thus are unable to provide consent to participate in clinical research. The U.S. Food and Drug Administration (FDA) has approved ProTECT III and other emergency neuroscience research under a set of special rules called “Exception from Informed Consent” (EFIC). The U.S. Department of Health and Human Services (HHS) and Rhode Island state law also recognize and allow EFIC. The research team will attempt to reach the patient’s legally authorized representative or surrogate decision-maker, usually a family member or next of kin. However, since the study drug must be administered soon after injury to be effective , EFIC allows patients to be enrolled in ProTECTIII without consent of the legally authorized representative or other surrogate decision-maker. The study team will also attempt to obtain informed consent, even after a patient has been enrolled in the study.

The EFIC rules allow research studies in certain special emergency situations to be conducted without informed consent. EFIC standards apply only when all of the following conditions are met:

  1. The person is in a life-threatening situation

  2. Current treatments are unproven or unsatisfactory

  3. The study might provide direct benefit to the person

  4. It is not possible to obtain informed consent from: A) the person because of injury or B) the person’s surrogate decision maker because there is a very short amount of time required to treat the medical condition.

Traumatic brain injury is the leading cause of death and disability in children and adults ages 1 to 44. In calendar year 2011, Rhode Island Hospital treated approximately 3,800 patients who had sustained a traumatic brain injury.

Additional information on ProTECTIII, EFIC, or joining an “opt-out registry should you not wish to participate in ProTECTIII can be found at www.protectiii.com or by contacting the Rhode Island Hospital research team at 401-444-3813.