Study Tests Using Progesterone to Treat Brain Injuries
Feb. 10, 2010 CONTACT: David Olejarz dolejar1@hfhs.org 313.874.4094
Study to Test Using Progesterone for Treating Traumatic Brain Injuries
DETROIT - Henry Ford Hospital will evaluate the effectiveness of using the hormone progesterone to treat traumatic brain injuries without first obtaining patients' informed consent as part of a national research study.
During emergency conditions federal regulations allow research to be performed without the informed consent of patients who are unconscious at the time. As soon as family members are available or the patients awaken their consent is sought to continue their participation in the study.
Called ProTECT, the study aims to determine if progesterone can decrease the disability and death associated with TBI, the leading cause of death and disability in children and adults under age 44, according to the Brain Trauma Foundation. Multiple animal studies have demonstrated that progesterone may decrease brain damage caused by a traumatic brain injury.
Progesterone is a naturally occurring hormone that regulates ovulation and menstruation in females. It is also present in small amounts in the brain and helps regulate normal brain function in men and women.
A traumatic brain injury, or TBI, is a blow or jolt to the head that disrupts brain function. An estimated 1.4 million people suffer a traumatic brain injury every year, and 50,000 die from it. Most of these injuries are caused by motor vehicle accidents, physical assaults and falls. TBI is also considered the signature wound of soldiers injured during the Iraq war.
The double-blind study will evaluate patients who suffer moderate to severe traumatic brain injuries and are taken to Henry Ford, DMC Detroit Receiving, DMC Sinai Grace and Beaumont, Royal Oak hospitals within four hours of the injury to be considered for the study. Enrolled patients will be randomly given either progesterone intravenously or a placebo, a fake version of the study drug.
The study is funded by the National Institute of Neurological Diseases and Stroke and involves 17 hospitals across the country.
Henry Ford's Institutional Review Board, Wayne State University's Human Investigation Committee and Beaumont's Human Investigation Committee will review and monitor the study.
For more information, visit www.detroitprotect.org
