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

Hemorrhagic Shock Clinical Trial

— RESCUE-Shock  

Official title:

Resuscitative Endocrinology: (RESCUE - Shock): A Phase II Trial to Evaluate the Effects of Single Dose Intravenous Premarin for Treatment of Patients With Hemorrhagic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973102
• Other study ID #: RESCUE - Shock
• Status: Completed
• Phase: Phase 2
• Start date: July 2009
• Est. completion date: May 2012

Study information

• Verified date: March 2020
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhagic Shock
• Shock
• Shock, Hemorrhagic

Intervention

Drug:
• Premarin IV
One time dose of Premarin IV
• Placebo
One time dose of placebo.

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas
United States	Parkland Hospital	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Resuscitation Outcomes Consortium, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acute Respiratory Distress Syndrome (ARDS) Free Survival	ARDS is a life-threatening condition characterized by inflammation of the lungs. The trial measures the number of days alive and without ARDS within 28 days post injury. Patients who die within 28 days are given value of 0, similarly, patients who live 28 days but have ARDS for all 28 days. A higher score (greater days) indicates better prognosis. Exudative stage is 0-6 days, proliferative stage is 7-10 days, Fibrotic stage is >10-14 days.	28 days