Status:
COMPLETED
Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen-Traumatic Hemorrhagic Shock (RESCUE - Shock)
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
University of Washington
Resuscitation Outcomes Consortium
Conditions:
Hemorrhagic Shock
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
Based on 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 im...
Detailed Description
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 hu...
Eligibility Criteria
Inclusion
- Age≥ 18 yrs or \< 50 yrs
- Blunt or penetrating trauma leading to presumed hemorrhagic shock
- Pre-hospital or ED systolic blood pressure \< 90
- Receiving medical treatment in the Emergency Department (ED) of Parkland Hospital or Baylor University Medical Center Emergency Department, Level I Trauma Centers in Dallas, Texas
Exclusion
- Those who would receive the study drug \> 120 minutes after the traumatic event
- Time of injury is unknown
- Known indication for IV estrogen
- Known contraindication for estrogen
- Estimated age \<18 or \> 50 years
- Cardiopulmonary Resuscitation (CPR) prior to randomization
- Known incarceration
- Severe hypothermia (suspected T \< 28° C)
- Drowning or asphyxia due to hanging
- Burns total body surface area (TBSA) \> 20%
- Isolated penetrating injury to the head
- Known inclusion in another interventional trial related to this traumatic event prior to randomization
- Known legal do not resuscitate (DNR) orders in place prior to randomization
- Recognized spinal cord injury prior to study drug administration
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00973102
Start Date
July 1 2009
End Date
May 1 2012
Last Update
March 19 2020
Active Locations (2)
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1
Parkland Hospital
Dallas, Texas, United States, 75235
2
Baylor University Medical Center
Dallas, Texas, United States, 75246