Resuscitative Endocrinology:Single-dose Clinical Uses for Estrogen-Traumatic Brain Injury (RESCUE-TBI)
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|ClinicalTrials.gov Identifier: NCT00973674|
Recruitment Status : Completed
First Posted : September 9, 2009
Results First Posted : November 12, 2019
Last Update Posted : November 12, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
One time dose of Placebo
Other Name: Infivite Multivitamin
- 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.
- 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.
- 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.
- 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.
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
|United States, Texas|
|Dallas, Texas, United States, 75235|
|Baylor University Medical Center|
|Dallas, Texas, United States, 75246|
|Principal Investigator:||Jane G Wigginton, MD||UT Southwestern Medical Center Dallas|
|Study Chair:||Schmickers Rob||University of Washington|