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Trial record 2 of 158 for:    estrogen AND brain

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00973674
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : May 1, 2014
University of Washington
Resuscitation Outcomes Consortium
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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 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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Premarin IV Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Premarin Drug: Premarin IV
One time dose of Premarin IV
Other Name: IV Estrogen

Placebo Comparator: Placebo Drug: Placebo
One time dose of Placebo

Primary Outcome Measures :
  1. Short term neurological outcome [ Time Frame: 28 Days ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00973674

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United States, Texas
Parkland Hospital
Dallas, Texas, United States, 75235
Baylor University Medical Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
University of Texas Southwestern Medical Center
University of Washington
Resuscitation Outcomes Consortium
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Principal Investigator: Jane G Wigginton, MD UT Southwestern Medical Center Dallas

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Responsible Party: University of Texas Southwestern Medical Center Identifier: NCT00973674     History of Changes
Other Study ID Numbers: RESCUE-TBI
First Posted: September 9, 2009    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Estrogens, Conjugated (USP)
Wounds and Injuries
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs