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NCT00973674 · ClinicalTrials.gov registry record · Phase 2

Resuscitative Endocrinology:Single-dose Clinical Uses for Estrogen-Traumatic Brain Injury

A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.

Completed
Registry status
Phase 2
Development phase
50
Enrollment target

NCT00973674 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 50 participants.

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The verdict

NCT00973674, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.

COMPLETED
Registry status
Phase 2
Development phase
50 participants
Enrollment target

Study Summary

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.

Interventions

  • DRUG Placebo
  • DRUG Premarin IV

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2009-07
Est. Completion 2012-05
Phase Phase 2

What the Registry Record Tells You About NCT00973674

The ClinicalTrials.gov registry entry for NCT00973674 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00973674 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00973674 about?

NCT00973674 is a clinical study titled "Resuscitative Endocrinology:Single-dose Clinical Uses for Estrogen-Traumatic Brain Injury". 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 te...

What is the current status of trial NCT00973674?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2009-07. Estimated completion is 2012-05.

What interventions are being tested in trial NCT00973674?

The interventions under investigation include: Placebo (DRUG), Premarin IV (DRUG).

Who is sponsoring clinical trial NCT00973674?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.