Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen - Traumatic Hemorrhagic Shock (RESCUE - Shock)
Annually in the United States, approximately 30 million people require treatment for traumatic injuries in emergency departments. Two million of these patients require hospitalization, with several hundred thousand ultimately dying, often due to extreme blood loss. Importantly, these traumatic injuries are the leading cause of death and disability for children and young adults under the age of 44, with the total cost of trauma in the U.S. approaching $260 billion each year.
Despite advances in pre-hospital care, early resuscitation, surgical interventions and intensive care monitoring aimed at the primary traumatic injury, many survivors never recover. A significant cause of this mortality and morbidity is thought due to potentially preventable secondary injury, namely oxidant injury, inflammation, and apoptosis beginning in the first few hours after the severe traumatic event.
In spite of 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 hemorrhagic shock 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 hemorrhagic shock will safely reduce secondary injury, and improve survival.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen - Traumatic Hemorrhagic Shock (RESCUE - Shock): A Phase II Trial to Evaluate the Effects of A Single Dose of Intravenous Premarin for the Treatment of Patients With Hemorrhagic Shock|
- Survival [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
- Examine effects of IV estrogen vs. placebo in patients with traumatic hemorrhagic shock: Mortality; levels of injury markers & sex steroids; Glasgow Outcomes Scale (GOSE), DRS, cognitive, neurological & functional outcomes in those with TBI; safety [ Time Frame: Up to 6 months post-injury ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
|Experimental: Premarin IV||
Drug: Premarin IV
One time dose of Premarin IV
Other Name: Estrogen IV
|Placebo Comparator: Placebo||
One time dose of placebo.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00973102
|United States, Texas|
|Dallas, Texas, United States, 75235|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|