Not Signed In -
Traumatic Brain Injury |
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Clinical Trial: Progesterone Treatment of Blunt Traumatic Brain Injury
This study is currently recruiting patients.
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Purpose
The purpose of this study is to determine if progesterone treatment safely reduces brain swelling and damage after injury.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Traumatic Brain Injury | Drug: IV Progesterone | Phase I Phase II |
MedlinePlus related topics: Head and Brain Injuries
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Expanded Access Assignment, Safety Study
Official Title: ProTECT: Single Center, Phase II (pilot), Double Blind, 4:1 Randomized, Placebo Controlled Clinical Trial for Progesterone Treatment of Moderate and Severe Blunt TBI
Further Study Details:
Expected Total Enrollment: 100
Study start: May 2002; Expected completion: May 2004
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Blunt head trauma occuring within 11 hours
- Ages 18 years and older (or Tanner Score of 5)
- Index GCS between 4 and 12
Exclusion Criteria:
- Spinal cord injury
- Penetrating head trauma
- Cardiopulmonary arrest upon ECC arrival
- Status Epilepticus upon ECC arrival
- Systolic BP < 90mmHG upon ECC arrival
- Pulse Ox of < 90 (or pO2 < 60)
- Prisoners or incarcerated individuals
- Past Hx of significant intercranial pathology
- Pregnant females
- Blood alcohol level > 250 mg/dl
- Non-English speakers (a Spanish version of the ICF is currently being developed)
- Allergy(s) to soy, egg, or progesterone
- Active breast or reproductive organ cancer(s)
- Previous head injury or stroke within the past 6 weeks
Location and Contact Information
Arthur L Kellermann, MD, MPH 404-778-2600 akell01@sph.emory.edu
Pamela L Clark, RN, CCRC 404-712-8327 plclark@emory.edu
Pamela L Clark, RN, CCRC 404-712-8327 plclark@emory.edu
Georgia
Emory University School of Medicine - Dept. of Emergency Medicine, Atlanta, Georgia, 30322, United States; Recruiting
Arthur L Kellermann, MD, MPH, Principal Investigator
David W Wright, MD, Sub-Investigator
David W Wright, MD, Sub-Investigator
Study chairs or principal investigators
Arthur L Kellermann, MD, MPH, Principal Investigator, Chairman - Emory University Dept. of Emergency Medicine
More Information
Study ID Numbers: 1 R01 NS-39097-01A1
Record last reviewed: January 2004
Last Updated: October 13, 2004
Record first received: November 4, 2002
ClinicalTrials.gov Identifier: NCT00048646
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: January 2004
Last Updated: October 13, 2004
Record first received: November 4, 2002
ClinicalTrials.gov Identifier: NCT00048646
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005
Resources
- Brain Injury (Centers for Disease Control and Prevention)
- Brain Injury (National Institute of Neurological Disorders and Stroke)
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