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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
Sponsor:
Collaborators:
University of Washington
Resuscitation Outcomes Consortium
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Traumatic Brain Injury
Interventions Drug: Premarin IV
Drug: Placebo
Enrollment 50
Recruitment Details Clinical sites enrolled men and women age 18 to 55 who experienced severe traumatic brain injury in the EMS setting between September 2009 and January 2012.
Pre-assignment Details  
Arm/Group Title Premarin IV Placebo
Hide Arm/Group Description

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

Premarin IV: One time dose of Premarin IV

Patients randomized to receive a single dose of placebo IV. Due to 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.

Placebo: One time dose of Placebo

Period Title: Overall Study
Started 24 26
Completed 22 26
Not Completed 2 0
Reason Not Completed
Protocol Violation             2             0
Arm/Group Title Premarin IV Placebo Total
Hide Arm/Group Description

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

Premarin IV: One time dose of Premarin IV

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.

Placebo: One time dose of Placebo

Total of all reporting groups
Overall Number of Baseline Participants 22 26 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants 26 participants 48 participants
31.9
(17 to 52)
34.3
(16 to 65)
33.3
(16 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 26 participants 48 participants
Female
3
  13.6%
3
  11.5%
6
  12.5%
Male
19
  86.4%
23
  88.5%
42
  87.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 26 participants 48 participants
22 26 48
1.Primary Outcome
Title Percent Passing the Galveston Orientation Amnesia Test (GOAT) Within 28 Days Post Injury
Hide Description 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.
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premarin IV Placebo
Hide Arm/Group Description:

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

Premarin IV: One time dose of Premarin IV

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.

Placebo: One time dose of Placebo

Overall Number of Participants Analyzed 22 26
Measure Type: Count of Participants
Unit of Measure: Participants
12
  54.5%
14
  53.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin IV, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Barnard's unconditional Exact Test
Comments [Not Specified]
2.Secondary Outcome
Title 28-day Mortality
Hide Description 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.
Time Frame 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premarin IV Placebo
Hide Arm/Group Description:

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

Premarin IV: One time dose of Premarin IV

Patients randomized to receive a single dose of placebo IV. Due to 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.

Placebo: One time dose of Placebo

Overall Number of Participants Analyzed 22 26
Measure Type: Number
Unit of Measure: participants
7 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin IV, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .033
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.67
Confidence Interval (2-Sided) 95%
0.74 to 3.77
Estimation Comments [Not Specified]
3.Secondary Outcome
Title 6-month Glasgow Outcomes Scale- Extended (GOSE) Score
Hide Description 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.
Time Frame Up to 6 months post-injury
Hide Outcome Measure Data
Hide Analysis Population Description
The study specifically measures long-term GOSE, defined as post 6 months. Six month follow-up were not available for all patients and thus the lower sample size. As a secondary measure, missing values were not imputed.
Arm/Group Title Premarin IV Placebo
Hide Arm/Group Description:

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

Premarin IV: One time dose of Premarin IV

Patients randomized to receive a single dose of placebo IV. Due to 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.

Placebo: One time dose of Placebo

Overall Number of Participants Analyzed 18 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.00  (2.85) 4.82  (2.58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Premarin IV, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .35
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Acute Respiratory Distress Syndrome (ARDS) Free Survival
Hide 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 indicates better prognosis.
Time Frame Days 0-28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Premarin IV Placebo
Hide Arm/Group Description:

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

Premarin IV: One time dose of Premarin IV

Patients randomized to receive a single dose of placebo IV. Due to 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.

Placebo: One time dose of Placebo

Overall Number of Participants Analyzed 22 26
Mean (Standard Deviation)
Unit of Measure: days
18.9  (13.2) 24.1  (8.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Premarin IV Placebo
Hide Arm/Group Description

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

Premarin IV: One time dose of Premarin IV

Patients randomized to receive a single dose of placebo IV. Due to 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.

Placebo: One time dose of Placebo

All-Cause Mortality
Premarin IV Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Premarin IV Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/22 (36.36%)      13/26 (50.00%)    
Infections and infestations     
Pneumonia   4/22 (18.18%)  4 9/26 (34.62%)  9
Bloodstream infection   2/22 (9.09%)  2 3/26 (11.54%)  3
Urinary tract infection   2/22 (9.09%)  2 5/26 (19.23%)  5
Wound infection   2/22 (9.09%)  2 1/26 (3.85%)  1
Pseudomembranous colitis   0/22 (0.00%)  0 1/26 (3.85%)  1
Line infection   0/22 (0.00%)  0 1/26 (3.85%)  1
Vascular disorders     
Pulmonary embolus   1/22 (4.55%)  1 0/26 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Premarin IV Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/22 (0.00%)      0/26 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Scott Emerson, PhD
Organization: University of Washington
Phone: 206-616-6678
EMail: semerson@uw.edu
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00973674    
Other Study ID Numbers: RESCUE-TBI
First Submitted: July 14, 2009
First Posted: September 9, 2009
Results First Submitted: April 1, 2016
Results First Posted: November 12, 2019
Last Update Posted: November 12, 2019