|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Texas Southwestern Medical Center |
|---|---|
| Collaborators: |
University of Washington Resuscitation Outcomes Consortium |
| Information provided by: | University of Texas Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00973102 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemorrhagic Shock |
Drug: Premarin IV Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| 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 |
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Premarin IV |
Drug: Premarin IV
One time dose of Premarin IV
Other Name: Estrogen IV
|
| Placebo Comparator: Placebo |
Drug: Placebo
One time dose of placebo.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jane G Wigginton, MD | 214-648-2767 | jane.wigginton@UTSW.edu |
| Contact: Victoria Warren | 214-648-9491 | Victoria.Warren@UTSW.edu |
| United States, Texas | |
| Parkland Hospital | Recruiting |
| Dallas, Texas, United States, 75235 | |
| Contact: Jane G Wigginton, MD 214-648-2767 jane.wigginton@UTSW.edu | |
| Principal Investigator: Jane G Wigginton, MD | |
| Baylor University Medical Center | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Claudia Mattil 214-820-9626 Claudia.Mattil@baylorhealth.edu | |
| Principal Investigator: Michael Ramsay, MD | |
| Sub-Investigator: Michael Foreman, MD | |
More Information
| Responsible Party: | Jane G. Wigginton, MD / Assistant Professor, UT Southwestern Medical Center |
| ClinicalTrials.gov Identifier: | NCT00973102 History of Changes |
| Other Study ID Numbers: | RESCUE - Shock |
| Study First Received: | July 19, 2009 |
| Last Updated: | June 27, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Shock Shock, Hemorrhagic Pathologic Processes Hemorrhage Estrogens, Conjugated (USP) |
Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |