Monday, June 29, 2009
DALLAS — June 29, 2009 — UT Southwestern Medical Center researchers are conducting two pilot clinical trials to determine whether a single, early dose of estrogen can improve survival and neurological outcomes after severe traumatic brain injury or traumatic hemorrhagic shock.
In these double-blind studies, male patients transported to Parkland Memorial Hospital following severe traumatic brain injury or severe blood loss associated with a traumatic injury will be assigned randomly to receive either Premarin (estrogen) or a placebo intravenously after arriving in the emergency department.
Estrogen or a placebo will be administered as a single-dose within two hours of injury. The researchers will measure biomarkers of injury and repair in different body fluids during the first few days after injury, and also will evaluate survival and neurological outcomes.
Despite advances in surgical interventions and intensive care management, about 35 percent of patients with severe traumatic brain injury and hemorrhagic shock die. Many survivors do not fully recover and are left with permanent disability.
"Following traumatic brain injury or hemorrhagic shock, secondary injury, such as inflammation, begins rapidly and greatly worsens the initial injury," said Dr. Jane Wigginton, assistant professor of emergency medicine at UT Southwestern and the trials' principal investigator. "Hundreds of animal studies have shown that estrogen significantly reduces secondary injury. Those studies give us hope that this new therapy offers considerable promise and minimal risk following one dose in patients with life-threatening traumatic injuries."
Dr. James Simpkins, chair of pharmacology and neuroscience at the University of North Texas Health Science Center at Fort Worth, initially discovered in 1994 in animals that estrogens protect brains from damage.
"There are now several hundred high-quality animal studies demonstrating the effectiveness of estrogens in protecting the brain from the damaging effects of traumatic brain injury, stroke, hemorrhagic shock and chemical injury," said Dr. Simpkins. "These trials will be the first ever critical assessment of the effects of rapid intervention with estrogen on the outcome of traumatic brain injury in a human population."
Intravenous estrogen has been used safely for decades in both men and women to treat excessive bleeding of the uterus and prostate cancer. While animal studies have found that estrogen reduces inflammation and minimizes secondary injury, the effects of estrogen have not been tested in patients with traumatic brain injury and severe bleeding after a traumatic event.
Dr. Wigginton said for this study, only men are being given a dose of estrogen; 70 percent of trauma patients with severe brain injury or blood loss are young males. Limiting the study to men, who represent the most frequently affected population, also will remove the confounders of potentially high estrogen levels that might occur naturally in women, or be caused by birth control pills or hormone replacement therapy.
Because patients will be critically ill and the drug needs to be given rapidly following trauma, they will not be able to give informed consent for the study. Area residents who want to be excluded can opt out by calling 214-648-6726. Those individuals will be given a special wristband to alert doctors in the emergency department that they don't want to participate in the study. Researchers anticipate enrolling 50 patients in each study.
"We are highly enthusiastic about the evaluation of estrogen as an acute treatment in patients with traumatic brain injury and severe blood loss, given the significant benefit demonstrated in animal studies and safety data in humans prescribed intravenous estrogen for other indications," said Dr. Ahamed Idris, professor of emergency medicine at UT Southwestern. "It is our greatest hope that these groundbreaking studies will soon translate into improved survival and neurological outcomes in trauma patients around the world."
### About UT Southwestern:
UT Southwestern Medical Center, one of the premier medical centers in the nation, integrates pioneering biomedical research with exceptional clinical care and education. Its more than 2,200 faculty members — including four Nobel Prize winners — are responsible for groundbreaking medical advances and are committed to translating science-driven research quickly to new clinical treatments. UT Southwestern faculty and residents provide care to nearly 97,000 hospitalized patients and oversee 1.8 million outpatient visits a year.
Physicians care for patients in the Dallas-based UT Southwestern Medical Center; in Parkland Health & Hospital System, which is staffed primarily by UT Southwestern physicians; and in its affiliated hospitals, Children's Medical Center Dallas and the VA North Texas Health Care System. Media Contact:
214-648-3404 email@example.com About Parkland:
Parkland Health & Hospital System is one of the largest public hospital systems in the country with 685 operating beds and more than 8,000 employees. Services include a Level I Trauma Center, the second largest civilian burn center in the U.S. and a Level III Neonatal Intensive Care Unit. The hospital averages about 43,000 admissions annually. The system also includes 11 community-based clinics, 11 school-based clinics and numerous outreach and education programs. For more information, visit www.parklandhospital.com. Media Contact:
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Dr. Jane Wigginton -- http://www.utsouthwestern.edu/findfac/professional/0
Assistant Vice President, Public Affairs