Clinical Trial: Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen - Traumatic Hemorrhagic Shock (RESCUE - Shock)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Do
Brief Summary:
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.
Detailed Summary:
Sponsor: University of Texas Southwestern Medical Center
Current Primary Outcome: Survival [ Time Frame: 28 Days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Examine the effects of IV estrogen vs. placebo for treating patients with traumatic hemorrhagic shock: Mortality; levels of injury markers and sex steroids; GOSE, DRS, cognitive, neurological and functional outcomes in those with TBI; safety [ Time Frame: Up to 6 months post-injury ]
Information By: University of Texas Southwestern Medical Center
Dates:
Date Received: July 19, 2009
Date Started: July 2009
Date Completion:
Last Updated: April 4, 2014
Last Verified: April 2014
