Phase 2 N=50 Randomized Quadruple-blind Treatment

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

Hemorrhagic Shock

Bottom Line

View on ClinicalTrials.gov: NCT00973102 ↗

Enrolled (actual)

Serious AEs

25.0%

Results posted

Mar 2020

Primary outcome: Primary: Survival — 16; 21 participants — p=.252

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Premarin IV (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Texas Southwestern Medical Center
Primary completion: Jan 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Survival	16; 21	.252
SECONDARY Acute Respiratory Distress Syndrome (ARDS) Free Survival	3.00; 3.33	.895

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.

Eligibility Criteria

Inclusion Criteria

Age≥ 18 yrs or 120 minutes after the traumatic event
Time of injury is unknown
Known indication for IV estrogen
Known contraindication for estrogen
Estimated age 50 years
Cardiopulmonary Resuscitation (CPR) prior to randomization
Known incarceration
Severe hypothermia (suspected T 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00973102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.