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Progesterone Treatment of Blunt Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00048646
Recruitment Status : Completed
First Posted : November 6, 2002
Last Update Posted : September 19, 2014
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
David Wright, Emory University

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

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: IV Progesterone Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Study Start Date : May 2002
Primary Completion Date : September 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: placebo
placebo
Drug: IV Progesterone
Experimental: IV progesterone
IV progesterone
Drug: IV Progesterone



Primary Outcome Measures :
  1. neurological outcome [ Time Frame: 30 days ]
    GOS, DRS, and GOAT



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00048646


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

Publications:
Responsible Party: David Wright, Co-Investigator, Project Lead, Emory University
ClinicalTrials.gov Identifier: NCT00048646     History of Changes
Other Study ID Numbers: 0433-2001
1R01NS039097-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2002    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014

Keywords provided by David Wright, Emory University:
TBI
ProTECT

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
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