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Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen - Traumatic Brain Injury (RESCUE - TBI)

This study has been completed.
Sponsor:
Collaborators:
University of Washington
Resuscitation Outcomes Consortium
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00973674
First received: July 14, 2009
Last updated: April 4, 2014
Last verified: April 2014

July 14, 2009
April 4, 2014
July 2009
January 2012   (final data collection date for primary outcome measure)
Short term neurological outcome [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
Short term neurological outcome [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00973674 on ClinicalTrials.gov Archive Site
Examine the effects of IV estrogen vs. placebo for treating patients with severe TBI: Mortality, Glasgow Outcomes Scale- Extended (GOSE), DRS, cognitive, neurological and functional outcomes, levels of injury markers and sex steroids, and safety [ Time Frame: Up to 6 months post-injury ] [ Designated as safety issue: No ]
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 [ Time Frame: Up to 6 months post-injury ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen - Traumatic Brain Injury
A Phase II Trial to Evaluate the Effects of A Single Dose of Intravenous Premarin for the Treatment of Severe Traumatic Brain Injury

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Traumatic Brain Injury
  • Drug: Premarin IV
    One time dose of Premarin IV
    Other Name: IV Estrogen
  • Drug: Placebo
    One time dose of Placebo
  • Experimental: Premarin
    Intervention: Drug: Premarin IV
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
May 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00973674
RESCUE-TBI
Yes
University of Texas Southwestern Medical Center
University of Texas Southwestern Medical Center
  • University of Washington
  • Resuscitation Outcomes Consortium
Principal Investigator: Jane G Wigginton, MD UT Southwestern Medical Center Dallas
University of Texas Southwestern Medical Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP