Health Science Center and the University of Texas Southwestern Medical Center began a clinical trial last week at the Parkland Memorial Hospital in Dallas, Texas to determine the effects of administering a one-time dose of estrogen to traumatic brain injury patients. The researchers hope to establish the use of estrogen worldwide in cases of severe brain trauma.
This study follows on the tail of earlier research which demonstrated that estrogen, when administered within 2 hours after the injury, reduced long-term neurological damage and increased the survival rate in rats with brain injuries.
Scientists have also observed that women with naturally high levels of estrogen suffer less severe brain damage and have a higher survival rate than both men and women with lower levels of estrogen.
The current study presented researchers with ethical difficulties due to the impossibility of confirming informed consent from patients, as estrogen must be administered within 2 hours of sustaining a brain injury in order to be effective.
Earlier studies show that the damage to the brain is more permanent after 6 to 10 hours have passed, thus they are forced to treat patients in the study without their consent. While consent is impossible to attain from an unconscious patient, doctors and researchers said they would make every effort to contact loved ones, family members, and/or guardians to gain consent.
The study focuses on 50 men from age 18 to 50 who have sustained severe brain injuries. Participants will receive either estrogen or a placebo to determine the benefits of estrogen in protecting the brain immediately following trauma. Tens of thousands of accident victims die each year due to severe brain injuries. Researchers hope that this and future studies and clinical trials will allow doctors treating severe brain injuries to reduce both the amount of long term brain damage and the number of patient deaths.
Estrogen has been used safely and successfully for years in treating patients with prostate cancer and uterine hemorrhaging. Before the study began, researchers were required to seek consent from the Dallas community and to offer opt-out bracelets to those not wishing to receive estrogen in the event of sustaining a life-threatening brain injury. It was not reported how consent was attained, nor how many people chose to opt out of the study.