Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen - Traumatic Brain Injury
Information source: University of Texas Southwestern Medical Center
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Traumatic Brain Injury
Intervention: Premarin IV (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Texas Southwestern Medical Center Official(s) and/or principal investigator(s):
Jane G Wigginton, MD, Principal Investigator, Affiliation: UT Southwestern Medical Center Dallas
Overall contact:
Jane G Wigginton, MD, Phone: 214-648-2917, Email: jane.wigginton@UTSW.edu
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.
Clinical Details
Official title: A Phase II Trial to Evaluate the Effects of A Single Dose of Intravenous Premarin for the Treatment of Severe Traumatic Brain Injury
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Short term neurological outcome
Secondary outcome: Examine the effects of IV estrogen vs. placebo for treating patients with severe TBI: Mortality, GOSE, DRS, cognitive, neurological and functional outcomes, levels of injury markers and sex steroids, and safety
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Male.
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. Male sex
5. 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.
6. Systolic blood pressure > 90 mm Hg
7. Receiving medical treatment in the Emergency Department (ED) of Parkland Hospital, a
Level I Trauma Center 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. Female sex
12. Known inclusion in another interventional trial related to this traumatic event prior
to randomization
13. Systolic blood pressure < or = 90 mm Hg
14. Known indication for IV estrogen
15. Known contraindication for estrogen (male sex is NOT a contraindication)
16. Sustained pulse oximeter < 90
17. Recognized spinal cord injury prior to study drug administration
Locations and Contacts
Jane G Wigginton, MD, Phone: 214-648-2917, Email: jane.wigginton@UTSW.edu
Parkland Hospital, Dallas, Texas 75235, United States; Recruiting
Jane G Wigginton, MD, Phone: 214-648-2767
Jane G Wigginton, MD, Principal Investigator
Additional Information
Starting date: July 2009
Last updated: September 4, 2009
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