Trial · NCT00973674
Resuscitative Endocrinology:Single-dose Clinical Uses for Estrogen-Traumatic Brain Injury
NCT00973674, Phase 2, Completed, University of Texas Southwestern Medical Center; results first posted 2019-11-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Resuscitative Endocrinology:Single-dose Clinical Uses for Estrogen-Traumatic Brain Injury. Trials, record NCT00973674. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00973674
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Resuscitative Endocrinology:Single-dose Clinical Uses for Estrogen-Traumatic Brain Injury
- NCT number
- NCT00973674
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Traumatic Brain Injury
- Interventions
- Premarin IV, Placebo
- First posted
- 2009-09-09
- Last updated
- 2019-11-12
- Results first posted
- 2019-11-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Passing the Galveston Orientation Amnesia Test (GOAT) Within 28 Days Post Injury | 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 | 28-day Mortality | 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. |
| Secondary | 6-month Glasgow Outcomes Scale- Extended (GOSE) Score | 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. |
| Secondary | Acute Respiratory Distress Syndrome (ARDS) Free Survival | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Passing the Galveston Orientation Amnesia Test (GOAT) Within 28 Days Post Injury | 28 Days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 28-day Mortality | 28 Days | participants | NUMBER | |
| SECONDARY | 6-month Glasgow Outcomes Scale- Extended (GOSE) Score | Up to 6 months post-injury | 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. | units on a scale | MEAN |
| SECONDARY | Acute Respiratory Distress Syndrome (ARDS) Free Survival | Days 0-28 | days | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Passing the Galveston Orientation Amnesia Test (GOAT) Within 28 Days Post Injury | Premarin IV | 12 | Participants | ||
| Percent Passing the Galveston Orientation Amnesia Test (GOAT) Within 28 Days Post Injury | Placebo | 14 | Participants | ||
| 28-day Mortality | Premarin IV | 7 | participants | ||
| 28-day Mortality | Placebo | 2 | participants | ||
| 6-month Glasgow Outcomes Scale- Extended (GOSE) Score | Premarin IV | 4.00 | Standard Deviation 2.85 | units on a scale | |
| 6-month Glasgow Outcomes Scale- Extended (GOSE) Score | Placebo | 4.82 | Standard Deviation 2.58 | units on a scale | |
| Acute Respiratory Distress Syndrome (ARDS) Free Survival | Premarin IV | 18.9 | Standard Deviation 13.2 | days | |
| Acute Respiratory Distress Syndrome (ARDS) Free Survival | Placebo | 24.1 | Standard Deviation 8.7 | days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Premarin IV | 24 | |
| Overall Study | STARTED | Placebo | 26 | |
| Overall Study | COMPLETED | Premarin IV | 22 | |
| Overall Study | COMPLETED | Placebo | 26 | |
| Overall Study | NOT COMPLETED | Premarin IV | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events14
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pneumonia | Infections and infestations | Premarin IV | 4 | 22 | 4 |
| serious | Pneumonia | Infections and infestations | Placebo | 9 | 26 | 9 |
| serious | Bloodstream infection | Infections and infestations | Premarin IV | 2 | 22 | 2 |
| serious | Bloodstream infection | Infections and infestations | Placebo | 3 | 26 | 3 |
| serious | Urinary tract infection | Infections and infestations | Premarin IV | 2 | 22 | 2 |
| serious | Urinary tract infection | Infections and infestations | Placebo | 5 | 26 | 5 |
| serious | Wound infection | Infections and infestations | Premarin IV | 2 | 22 | 2 |
| serious | Wound infection | Infections and infestations | Placebo | 1 | 26 | 1 |
| serious | Pseudomembranous colitis | Infections and infestations | Premarin IV | 0 | 22 | 0 |
| serious | Pseudomembranous colitis | Infections and infestations | Placebo | 1 | 26 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Premarin IV | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Premarin IV | 0 | 22 |
| Total, other adverse events | Placebo | 0 | 26 |
| Total, serious adverse events | Premarin IV | 8 | 22 |
| Total, serious adverse events | Placebo | 13 | 26 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Premarin IV vs Placebo: 28-day Mortality | Trial comparisons |
| Premarin IV vs Placebo: Percent Passing the Galveston Orientation Amnesia Test (GOAT) Within 28 Days Post Injury | Trial comparisons |
| Premarin IV vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00973674
GET https://conductscience.org/api/trials/v1/NCT00973674/registered