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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hemorrhagic Shock

In brief

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.

Key facts

Study ID

NCT00973102

Run by

University of Texas Southwestern Medical Center

People needed

50

Starts

2009-07-01

Expected to finish

2012-05-01

Last updated by the study team

2020-03-19

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Parkland Hospital — Dallas, Texas, United States
• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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