Oregon Health & Science University researchers are launching a study to evaluate progesterone treatments for traumatic brain injuries. Preliminary studies suggest the naturally occurring hormone stops damage to brain cells if it’s administered within four hours of a blow to the head or other traumatic head injury.
The study, called Progesterone for the Treatment of Traumatic Brain Injury or ProTECT™, is expected to begin June 10. Traumatic brain injury patients who arrive at the OHSU Emergency Department within four hours of their injuries and meet certain guidelines will receive intravenous infusions of progesterone for 96 hours or a placebo. Patients who are pregnant, younger than 18, in shock or suffering cardiac arrest will not receive the treatment. Prisoners, wards of the state and certain other individuals also will be excluded.
Participating research subjects will take a series of intellectual and motor skills tests six months after treatment to evaluate the effectiveness of the progesterone infusion.
“We are trying to determine whether traumatic brain injury patients who receive progesterone have a better recovery,” said Craig Warden, M.D., principal investigator and an associate professor of Emergency Medicine in the OHSU School of Medicine. “Progesterone levels are higher in women than men, and increase dramatically to help maintain a pregnancy. There are reasons to believe that progesterone may reduce the brain damage that occurs after a blunt force injury to the brain.”
The majority of patients will come from Multnomah, Clackamas and Washington counties, but can come from as far away as Tillamook and Wasco counties.
Because individuals who suffer from traumatic brain injury may be unconscious or unable to consent to being part of the study, the progesterone study will be conducted under Food and Drug Administration (FDA) guidelines that allow investigational research in certain life-threatening situations without prior consent. The federal regulations that allow this waiver of consent require representatives from the community be consulted and informed of the risks and benefits of the study.
OHSU has held a series of focus groups and meetings with community members, and made outreach to medical clinics and organizations for people who suffer from traumatic brain injuries. This study has been reviewed by the OHSU Institutional Review Board, and a Data Safety Monitoring Board comprising researchers and physicians not involved in the study will regularly review the data to ensure the safety of those involved.
People who do not wish to participate in this or other studies that allow investigative treatment in life- threatening situations without patient consent have several options to ensure they are not included:
-- Contact Mary Quick, study coordinator, at email@example.com or (503) 494-1186.
-- Request a “No Study” bracelet to wear from Mary Quick.
-- Go to www.protectiii.com and sign the national registry. Please note that in order to sign the registry you must have appropriate legal identification (i.e. driver’s license, government-issued identification card or a military identification card).
Funding for this study is provided by the National Institutes of Health and the National Institute for Neurological Disorders and Stroke.
Oregon Health & Science University is the state’s only health and research university, and Oregon’s only academic health center. OHSU is Portland's largest employer and the fourth largest in Oregon (excluding government). OHSU's size contributes to its ability to provide many services and community support activities not found anywhere else in the state. It serves patients from every corner of the state, and is a conduit for learning for more than 3,400 students and trainees. OHSU is the source of more than 200 community outreach programs that bring health and education services to every county in the state.