Resuscitative Endocrinology:Single-dose Clinical Uses for Estrogen-Traumatic Brain Injury

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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 the health care costs staggering for both initial care and rehabilitation, but the societal loss in terms of economic impact reaches into the billions of dollars annually in the U.S. alone. Despite advances in neurosurgical interventions and intensive care management, many survivors do not fully recover. A significant cause of this mortality and morbidity is thought due to potentially preventable secondary injury, namely oxidant injury, inflammation, and apoptosis in the penumbra (the area of brain surrounding the primary lesion, which is at-risk, but potentially salvageable), beginning in the first few hours after the severe traumatic event.

Despite 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 severe TBI and other similar processes, namely the early administration of estrogen, a strong anti-oxidant, anti-inflammatory and anti-apoptotic compound. Based on these encouraging results from animal studies, the investigators hypothesize that early administration of IV Premarin® in patients with severe TBI will safely reduce secondary brain injury, improve neurological outcomes, and improve survival.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Resuscitation Outcomes Consortium; University of Washington
• Treatments: Estrogens; Estrogens, Conjugated (USP)

Criteria

Inclusion Criteria:

1. Suspected blunt head injury

2. Estimated age of 18 - 50 years

3. Estimated time to study drug administration < 2 hours post-trauma

4. 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.

5. Systolic blood pressure > 90 mm Hg

6. 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. Legal Do Not Resuscitate (DNR) orders in place prior to randomization.

2. Known incarcerated individuals

3. Status epilepticus prior to study drug administration

4. Penetrating head trauma

5. Estimated time to study drug administration > 2 hours post-trauma

6. Injury time unknown

7. Cardiopulmonary Resuscitation (CPR) prior to study drug administration

8. Severe hypothermia (suspected T <28C)

9. Drowning or asphyxia due to hanging

10. Burns TBSA > 20% in adults

11. Known inclusion in another interventional trial related to this traumatic event prior to randomization

12. Systolic blood pressure < or = 90 mm Hg

13. Known indication for IV estrogen

14. Known contraindication for estrogen (male sex is NOT a contraindication)

15. Sustained pulse oximeter < 90

16. Recognized spinal cord injury prior to study drug administration