Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen-Traumatic Hemorrhagic Shock (RESCUE - Shock) (RESCUE-Shock)
Hemorrhagic Shock
About this trial
This is an interventional treatment trial for Hemorrhagic Shock
Eligibility Criteria
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
Sites / Locations
- Parkland Hospital
- Baylor University Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Premarin IV
Placebo
Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.
Patients who were randomized to receive a single dose of 0.5 mg/kg placebo. Due of the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with hemorrhagic shock.