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



Status:Completed
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 50
Updated:10/14/2017
Start Date:July 2009
End Date:May 2012

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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

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.


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 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
We found this trial at
2
sites
3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Dallas, Texas 75390
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