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

Primary Purpose

Hemorrhagic Shock

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Premarin IV
Placebo
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhagic Shock

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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 total body surface area (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

Sites / Locations

  • Parkland Hospital
  • Baylor University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Premarin IV

Placebo

Arm Description

Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.

Patients who were randomized to receive a single dose of 0.5 mg/kg placebo. 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 hemorrhagic shock.

Outcomes

Primary Outcome Measures

Survival
Survival is defined as the number of patients who were discharged from the hospital alive prior to 28 days post injury or the number of patients still alive in the hospital 28 days post injury. The trial examines the rate of enrolled patients on each arm who survived to 28 days.

Secondary Outcome Measures

Acute Respiratory Distress Syndrome (ARDS) Free Survival
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 (greater days) indicates better prognosis. Exudative stage is 0-6 days, proliferative stage is 7-10 days, Fibrotic stage is >10-14 days.

Full Information

First Posted
July 19, 2009
Last Updated
March 17, 2020
Sponsor
University of Texas Southwestern Medical Center
Collaborators
University of Washington, Resuscitation Outcomes Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT00973102
Brief Title
Resuscitative Endocrinology: Single-dose Clinical Uses for Estrogen-Traumatic Hemorrhagic Shock (RESCUE - Shock)
Acronym
RESCUE-Shock
Official Title
Resuscitative Endocrinology: (RESCUE - Shock): A Phase II Trial to Evaluate the Effects of Single Dose Intravenous Premarin for Treatment of Patients With Hemorrhagic Shock
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
University of Washington, Resuscitation Outcomes Consortium

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Based on 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.
Detailed Description
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Premarin IV
Arm Type
Experimental
Arm Description
Patients who were randomized to receive a single dose of 0.5 mg/kg Premarin® IV.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients who were randomized to receive a single dose of 0.5 mg/kg placebo. 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 hemorrhagic shock.
Intervention Type
Drug
Intervention Name(s)
Premarin IV
Other Intervention Name(s)
Estrogen IV
Intervention Description
One time dose of Premarin IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Infuvite Multivitamin
Intervention Description
One time dose of placebo.
Primary Outcome Measure Information:
Title
Survival
Description
Survival is defined as the number of patients who were discharged from the hospital alive prior to 28 days post injury or the number of patients still alive in the hospital 28 days post injury. The trial examines the rate of enrolled patients on each arm who survived to 28 days.
Time Frame
28 Days
Secondary Outcome Measure Information:
Title
Acute Respiratory Distress Syndrome (ARDS) Free Survival
Description
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 (greater days) indicates better prognosis. Exudative stage is 0-6 days, proliferative stage is 7-10 days, Fibrotic stage is >10-14 days.
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age≥ 18 yrs or < 50 yrs Blunt or penetrating trauma leading to presumed hemorrhagic shock Pre-hospital or ED systolic blood pressure < 90 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: Those who would receive the study drug > 120 minutes after the traumatic event Time of injury is unknown Known indication for IV estrogen Known contraindication for estrogen Estimated age <18 or > 50 years Cardiopulmonary Resuscitation (CPR) prior to randomization Known incarceration Severe hypothermia (suspected T < 28° C) Drowning or asphyxia due to hanging Burns total body surface area (TBSA) > 20% Isolated penetrating injury to the head Known inclusion in another interventional trial related to this traumatic event prior to randomization Known legal do not resuscitate (DNR) orders in place prior to randomization Recognized spinal cord injury prior to study drug administration
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rob Schmickers
Organizational Affiliation
University of Washington
Official's Role
Study Director
Facility Information:
Facility Name
Parkland Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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