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

NCT ID: NCT00973102

Last Updated: 2020-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2012-05-31

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.

Detailed Description

Annually in the United States, approximately 30 million people require treatment for traumatic injuries in emergency departments. Two million of these patients require hospitalization, with several hundred thousand ultimately dying, often due to extreme blood loss. Importantly, these traumatic injuries are the leading cause of death and disability for children and young adults under the age of 44, with the total cost of trauma in the U.S. approaching $260 billion each year.

Despite advances in pre-hospital care, early resuscitation, surgical interventions and intensive care monitoring aimed at the primary traumatic injury, many survivors never recover. A significant cause of this mortality and morbidity is thought due to potentially preventable secondary injury, namely oxidant injury, inflammation, and apoptosis beginning in the first few hours after the severe traumatic event.

In spite of the current bleak outlook for many of these patients, a series of animal investigations have uncovered a promising solution to the problem of the secondary injury seen in hemorrhagic shock and other similar processes, namely the early administration of estrogen, a strong anti-oxidant, anti-inflammatory and anti-apoptotic compound.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Premarin IV

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

Group Type: EXPERIMENTAL

Premarin IV

Intervention Type: DRUG

One time dose of Premarin IV

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One time dose of placebo.

Interventions

Premarin IV

One time dose of Premarin IV

Intervention Type: DRUG

Placebo

One time dose of placebo.

Intervention Type: DRUG

Other Intervention Names

Estrogen IV; Infuvite Multivitamin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Resuscitation Outcomes Consortium

NETWORK

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rob Schmickers

Role: STUDY_DIRECTOR

University of Washington

Locations

Parkland Hospital

Dallas, Texas, United States

Baylor University Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

RESCUE - Shock

Identifier Type: -

Identifier Source: org_study_id