CompletedPhase 2

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

United States50 participantsStarted 2009-07

Plain-language 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.

Who can participate

Age range18 Years – 50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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)

What they're measuring

Survival

Timeframe: 28 Days

Trial details

NCT IDNCT00973102

SponsorUniversity of Texas Southwestern Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-01

Results submitted2016-04-01

View on ClinicalTrials.gov More Hemorrhagic Shock trials