PROVIDENCE – Rhode Island Hospital is joining a national research study to assess the treatment of traumatic brain injury with the naturally occurring hormone progesterone. The multi-site study is funded by the National Institutes of Health and will be led locally by Dr. Lisa Merck of the department of emergency medicine. It is currently being conducted at 36 sites around the country.
Traumatic brain injury, 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, hospital officials said.
In 2011, Rhode Island Hospital treated approximately 3,800 people with traumatic brain injury, according to hospital spokeswoman Ellen Slingsby.
Nationally, nearly 2 million adults and children in the U.S. sustain traumatic brain injuries each year, resulting in approximately 50,000 deaths. Nearly 80,000 of those affected will require specialized care for the rest of their lives due to resulting disabilities.
A unique – and controversial – component of the study is that it requires an “Exception From Informed Consent,” which has been approved by federal and state agencies.
Many of the patients who may benefit from the treatment are unconscious or in critical condition, and cannot consent, according to Slingsby. “The clinical team will, of course, try to contact the appropriate decision-maker for each patient, but time is of the essence in these situations, so [the Exception from Informed Consent] allows the doctors/researchers to enroll appropriate patients without consent,” she said.
“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 clinical trial will help determine if progesterone, plus standard medical therapy, improves patient outcomes over standard medical therapy alone.”