Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen-Traumatic Hemorrhagic Shock (RESCUE - Shock)

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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 improve survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Resuscitation Outcomes Consortium; University of Washington
• Treatments: Estrogens; Estrogens, Conjugated (USP)

Criteria

Inclusion Criteria:

1. Age≥ 18 yrs or < 50 yrs

2. Blunt or penetrating trauma leading to presumed hemorrhagic shock

3. Pre-hospital or ED systolic blood pressure < 90

4. 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 Criteria:

1. Those who would receive the study drug > 120 minutes after the traumatic event

2. Time of injury is unknown

3. Known indication for IV estrogen

4. Known contraindication for estrogen

5. Estimated age <18 or > 50 years

6. Cardiopulmonary Resuscitation (CPR) prior to randomization

7. Known incarceration

8. Severe hypothermia (suspected T < 28° C)

9. Drowning or asphyxia due to hanging

10. Burns total body surface area (TBSA) > 20%

11. Isolated penetrating injury to the head

12. Known inclusion in another interventional trial related to this traumatic event prior to randomization

13. Known legal do not resuscitate (DNR) orders in place prior to randomization

14. Recognized spinal cord injury prior to study drug administration