Status:
COMPLETED
Resuscitative Endocrinology:Single-dose Clinical Uses for Estrogen-Traumatic Brain Injury
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
University of Washington
Resuscitation Outcomes Consortium
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief Summary
Each year in the United States alone, a third of a million persons are hospitalized for traumatic brain injury (TBI), of whom approximately 1/4 die. Most are less than 30 years of age. Not only are th...
Detailed Description
Early estrogen treatment has been tested in a myriad of animal models of resuscitation ranging from TBI and stroke to spinal cord injury, trauma-related hemorrhage, and sepsis. In these scenarios, stu...
Eligibility Criteria
Inclusion
- Suspected blunt head injury
- Estimated age of 18 - 50 years
- Estimated time to study drug administration \< 2 hours post-trauma
- Glasgow Come Scale (GCS) score of between 3 and 8 prior to intubation and/or sedation, due to difficulty of patient's cooperation in assessment after these interventions.
- Systolic blood pressure \> 90 mm Hg
- 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
- Legal Do Not Resuscitate (DNR) orders in place prior to randomization.
- Known incarcerated individuals
- Status epilepticus prior to study drug administration
- Penetrating head trauma
- Estimated time to study drug administration \> 2 hours post-trauma
- Injury time unknown
- Cardiopulmonary Resuscitation (CPR) prior to study drug administration
- Severe hypothermia (suspected T \<28C)
- Drowning or asphyxia due to hanging
- Burns TBSA \> 20% in adults
- Known inclusion in another interventional trial related to this traumatic event prior to randomization
- Systolic blood pressure \< or = 90 mm Hg
- Known indication for IV estrogen
- Known contraindication for estrogen (male sex is NOT a contraindication)
- Sustained pulse oximeter \< 90
- Recognized spinal cord injury prior to study drug administration
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00973674
Start Date
July 1 2009
End Date
May 1 2012
Last Update
November 12 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Parkland Hospital
Dallas, Texas, United States, 75235
2
Baylor University Medical Center
Dallas, Texas, United States, 75246