Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00973674
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborators:
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

Show Show detailed description

Layout table for study information
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 IV
Patients randomized to receive a single dose of 0.5 mg/kg Premarin® IV
Drug: Premarin IV
One time dose of Premarin IV
Other Name: IV Estrogen

Placebo Comparator: Placebo
Patients randomized to receive a single dose of placebo IV. Due of the faint yellow color of the reconstituted Premarin®, the placebo dose will be prepared with 0.14 ml of Vial 1 of Infuvite Adult Multivitamin and 14 ml of sterile water to generate a similar color and volume. This aliquot will be used only for those study patients who are randomized to the placebo arm. The placebo volume will be approximately equal to the volume which the patient would have received had the patient been randomized to the Premarin arm Considering the small amount of IV multivitamin needed for fluid tinting, it is not expected that the IV multivitamin will have any effect on patients with traumatic brain injury.
Drug: Placebo
One time dose of Placebo
Other Name: Infivite Multivitamin




Primary Outcome Measures :
  1. Percent Passing the Galveston Orientation Amnesia Test (GOAT) Within 28 Days Post Injury [ Time Frame: 28 Days ]
    The GOAT is a measure of early cognitive recovery following a severe traumatic injury. The score is determined after examination by health professionals with respect to orientation to person, place and time. On a scale 0 to 100, 76-100 represents normal recovery. The trial measures the percentage of patients who pass the Galveston Orientation Amnesia Test (GOAT) within 28 days post injury.


Secondary Outcome Measures :
  1. 28-day Mortality [ Time Frame: 28 Days ]
    Mortality is defined as the number of patients who died prior to 28 days post injury. Patients who are still in the hospital 28-days post injury are considered alive. The trial examines the rate of enrolled patients on each arm who died prior to 28 days post injury.

  2. 6-month Glasgow Outcomes Scale- Extended (GOSE) Score [ Time Frame: Up to 6 months post-injury ]
    The GOSE is a scale for functional outcome following a severe traumatic injury. The GOSE is an ordinal variable with the following categories: Dead, Vegetative State, Lower Severe Disability, Upper Severe Disability, Lower Moderate Disability, Upper Moderate Disability, Lower Good Recovery, and Upper Good Recovery. The GOSE score is determined by a structured interview with questions surrounding consciousness, independence inside and outside the home, social and leisure activities and return to normal life among others. A higher score is considered to be a better result. A lower score indicates a worse result. The scale is 1-8, level 1 minimum score, level 8 maximum score.

  3. Acute Respiratory Distress Syndrome (ARDS) Free Survival [ Time Frame: Days 0-28 ]
    ARDS is a life-threatening condition characterized by inflammation of the lungs. The trial measures the number of days alive and without ARDS within 28 days post injury. Patients who die within 28 days are given value of 0, similarly, patients who live 28 days but have ARDS for all 28 days. A higher score indicates better prognosis.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00973674


Locations
Layout table for location information
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
Investigators
Layout table for investigator information
Principal Investigator: Jane G Wigginton, MD UT Southwestern Medical Center Dallas
Study Chair: Schmickers Rob University of Washington
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00973674    
Other Study ID Numbers: RESCUE-TBI
First Posted: September 9, 2009    Key Record Dates
Results First Posted: November 12, 2019
Last Update Posted: November 12, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Estrogens
Estrogens, Conjugated (USP)
Wounds and Injuries
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs