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

Condition(s) targeted: Hemorrhagic Shock

Intervention: Premarin IV (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Texas Southwestern Medical Center

Overall contact:
Jane G Wigginton, MD, Phone: 214-648-2767, Email: jane.wigginton@UTSW.edu

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 these 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.

Official title: Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen - Traumatic Hemorrhagic Shock (RESCUE - Shock): A Phase II Trial to Evaluate the Effects of A Single Dose of Intravenous Premarin for the Treatment of Patients With Hemorrhagic Shock

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Survival

Secondary outcome: Examine the effects of IV estrogen vs. placebo for treating patients with traumatic hemorrhagic shock: Mortality; levels of injury markers and sex steroids; GOSE, DRS, cognitive, neurological and functional outcomes in those with TBI; safety

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

1. Male sex

2. Age≥ 18 yrs or < 50 yrs

3. Blunt or penetrating trauma leading to presumed hemorrhagic shock

4. Pre-hospital or ED systolic blood pressure < 90

5. Receiving medical treatment in the Emergency Department (ED) of Parkland Hospital, a Level I Trauma Center 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. Female sex

6. Estimated age <18 or > 50 years

7. Cardiopulmonary Resuscitation (CPR) prior to randomization

8. Known incarceration

9. Severe hypothermia (suspected T < 28° C)

10. Drowning or asphyxia due to hanging

11. Burns TBSA > 20%

12. Isolated penetrating injury to the head

13. Known inclusion in another interventional trial related to this traumatic event prior to randomization

14. Known legal do not resuscitate (DNR) orders in place prior to randomization

15. Recognized spinal cord injury prior to study drug administration

Jane G Wigginton, MD, Phone: 214-648-2767, Email: jane.wigginton@UTSW.edu

Parkland Hospital, Dallas, Texas 75235, United States; Recruiting
Jane G Wigginton, MD, Phone: 214-648-2767, Email: jane.wigginton@UTSW.edu
Jane G Wigginton, MD, Principal Investigator

Starting date: July 2009
Last updated: September 4, 2009