Resuscitative Endocrinology:Single-dose Clinical Uses for Estrogen-Traumatic Brain Injury
Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
Participant gender:
Summary
Each year in the United States alone, a third of a million persons are hospitalized for
traumatic brain injury (TBI), of whom approximately 1/4 die. Most are less than 30 years of
age. Not only are the health care costs staggering for both initial care and rehabilitation,
but the societal loss in terms of economic impact reaches into the billions of dollars
annually in the U.S. alone. Despite advances in neurosurgical interventions and intensive
care management, many survivors do not fully recover. A significant cause of this mortality
and morbidity is thought due to potentially preventable secondary injury, namely oxidant
injury, inflammation, and apoptosis in the penumbra (the area of brain surrounding the
primary lesion, which is at-risk, but potentially salvageable), beginning in the first few
hours after the severe traumatic event.
Despite the current bleak outlook for many of these patients, a series of animal
investigations have uncovered a promising solution to the problem of the secondary injury
seen in severe TBI and other similar processes, namely the early administration of estrogen,
a strong anti-oxidant, anti-inflammatory and anti-apoptotic compound. Based on these
encouraging results from animal studies, the investigators hypothesize that early
administration of IV Premarin® in patients with severe TBI will safely reduce secondary brain
injury, improve neurological outcomes, and improve survival.
Phase:
Phase 2
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborators:
Resuscitation Outcomes Consortium University of Washington