Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen - Traumatic Hemorrhagic Shock (RESCUE - Shock)

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:
NCT00973102
First received: July 19, 2009
Last updated: April 4, 2014
Last verified: April 2014
  Purpose

Annually in the United States, approximately 30 million people require treatment for traumatic injuries in emergency departments. Two million of these patients require hospitalization, with several hundred thousand ultimately dying, often due to extreme blood loss. Importantly, these traumatic injuries are the leading cause of death and disability for children and young adults under the age of 44, with the total cost of trauma in the U.S. approaching $260 billion each year.

Despite advances in pre-hospital care, early resuscitation, surgical interventions and intensive care monitoring aimed at the primary traumatic injury, many survivors never recover. A significant cause of this mortality and morbidity is thought due to potentially preventable secondary injury, namely oxidant injury, inflammation, and apoptosis beginning in the first few hours after the severe traumatic event.

In spite of 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 hemorrhagic shock 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 hemorrhagic shock will safely reduce secondary injury, and improve survival.


Condition Intervention Phase
Hemorrhagic Shock
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: Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen - Traumatic Hemorrhagic Shock (RESCUE - Shock): A Phase II Trial to Evaluate the Effects of A Single Dose of Intravenous Premarin for the Treatment of Patients With Hemorrhagic Shock

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Survival [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Examine effects of IV estrogen vs. placebo in patients with traumatic hemorrhagic shock: Mortality; levels of injury markers & sex steroids; Glasgow Outcomes Scale (GOSE), DRS, cognitive, neurological & functional outcomes in those with TBI; 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 IV Drug: Premarin IV
One time dose of Premarin IV
Other Name: Estrogen IV
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. Age≥ 18 yrs or < 50 yrs
  2. Blunt or penetrating trauma leading to presumed hemorrhagic shock
  3. Pre-hospital or ED systolic blood pressure < 90
  4. 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. Those who would receive the study drug > 120 minutes after the traumatic event
  2. Time of injury is unknown
  3. Known indication for IV estrogen
  4. Known contraindication for estrogen
  5. Estimated age <18 or > 50 years
  6. Cardiopulmonary Resuscitation (CPR) prior to randomization
  7. Known incarceration
  8. Severe hypothermia (suspected T < 28° C)
  9. Drowning or asphyxia due to hanging
  10. Burns TBSA > 20%
  11. Isolated penetrating injury to the head
  12. Known inclusion in another interventional trial related to this traumatic event prior to randomization
  13. Known legal do not resuscitate (DNR) orders in place prior to randomization
  14. 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: NCT00973102

Locations
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
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00973102     History of Changes
Other Study ID Numbers: RESCUE - Shock
Study First Received: July 19, 2009
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Shock
Shock, Hemorrhagic
Pathologic Processes
Hemorrhage
Estrogens
Estrogens, Conjugated (USP)
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014