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

• Age≥ 18 yrs or < 50 yrs
• Blunt or penetrating trauma leading to presumed hemorrhagic shock
• Pre-hospital or ED systolic blood pressure < 90
• 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

• Those who would receive the study drug > 120 minutes after the traumatic event
• Time of injury is unknown
• Known indication for IV estrogen
• Known contraindication for estrogen
• Estimated age <18 or > 50 years
• Cardiopulmonary Resuscitation (CPR) prior to randomization
• Known incarceration
• Severe hypothermia (suspected T < 28° C)
• Drowning or asphyxia due to hanging
• Burns total body surface area (TBSA) > 20%
• Isolated penetrating injury to the head
• Known inclusion in another interventional trial related to this traumatic event prior to randomization
• Known legal do not resuscitate (DNR) orders in place prior to randomization
• Recognized spinal cord injury prior to study drug administration