Clinical trial NCT00973102: Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen-Traumatic Hemorrhagic Shock (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemorrhagic Shock
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Resuscitation Outcomes Consortium
First posted: 2009-09-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Survival
timeFrame: 28 Days
Secondary outcomes:
measure: Acute Respiratory Distress Syndrome (ARDS) Free Survival
timeFrame: 28 days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Hospital
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
Study officials:
affiliation: University of Washington
name: Rob Schmickers
role: STUDY_DIRECTOR
References: