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

NCT00973102 | Completed Phase 2 Results DMC

• 1 other identifier: RESCUE - Shock
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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 improve survival.

Conditions

Hemorrhagic Shock

Outcome Measures

Primary Outcomes (1)

• Survival

  Survival is defined as the number of patients who were discharged from the hospital alive prior to 28 days post injury or the number of patients still alive in the hospital 28 days post injury. The trial examines the rate of enrolled patients on each arm who survived to 28 days.

  28 Days

Secondary Outcomes (1)

• Acute Respiratory Distress Syndrome (ARDS) Free Survival

  28 days

Study Arms (2)

Premarin IV

EXPERIMENTAL

Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.

Drug: Premarin IV

Placebo

PLACEBO COMPARATOR

Patients who were randomized to receive a single dose of 0.5 mg/kg placebo. Due of the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with hemorrhagic shock.

Drug: Placebo

Interventions

Premarin IV DRUG

One time dose of Premarin IV

Also known as: Estrogen IV

Premarin IV

Placebo DRUG

One time dose of placebo.

Also known as: Infuvite Multivitamin

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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 legal do not resuscitate (DNR) orders in place prior to randomization
• Recognized spinal cord injury prior to study drug administration

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• University of Washington: collaborator
• Resuscitation Outcomes Consortium: collaborator

Study Sites (2)

Parkland Hospital

Dallas, Texas, 75235, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Shock, Hemorrhagic

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Results Point of Contact

• Title: Scott Emerson, PhD
• Organization: University of Washington

semerson@uw.edu

206-616-6678

Study Officials

• Rob Schmickers

  University of Washington

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2009
• First Posted: September 9, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 19, 2020
• Results First Posted: March 19, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)