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Progesterone Treatment of Blunt Traumatic Brain Injury

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by Emory University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00048646
First received: November 4, 2002
Last updated: February 6, 2007
Last verified: May 2005
History of Changes
  Purpose

The purpose of this study is to determine if progesterone treatment safely reduces brain swelling and damage after injury.


Condition Intervention Phase
Traumatic Brain Injury
 Drug: IV Progesterone
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Emory University:

Estimated Enrollment: 100
Study Start Date: May 2002
Estimated Study Completion Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00048646

Locations
United States, Georgia
Emory University School of Medicine - Dept. of Emergency Medicine
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Arthur L Kellermann, MD, MPH Chairman - Emory University Dept. of Emergency Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00048646     History of Changes
Other Study ID Numbers: 1 R01 NS-39097-01A1
Study First Received: November 4, 2002
Last Updated: February 6, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
TBI
ProTECT

Additional relevant MeSH terms:
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
 Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013