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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
  Purpose

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 Intervention Phase
Traumatic Brain Injury
Drug: Premarin IV
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Short term neurological outcome [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 50
Study Start Date: July 2009
Study Completion Date: May 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00973674

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

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00973674     History of Changes
Other Study ID Numbers: RESCUE-TBI
Study First Received: July 14, 2009
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014