Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT00973102
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT00973102
Study Brief:
Protocol Section:
NCT00973102