Progesterone Treatment of Blunt Traumatic Brain Injury

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
David Wright, Emory University
ClinicalTrials.gov Identifier:
NCT00048646
First received: November 4, 2002
Last updated: September 4, 2013
Last verified: September 2013

November 4, 2002
September 4, 2013
May 2002
September 2013   (final data collection date for primary outcome measure)
neurological outcome [ Time Frame: 30 days ] [ Designated as safety issue: No ]
GOS, DRS, and GOAT
Not Provided
Complete list of historical versions of study NCT00048646 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Progesterone Treatment of Blunt Traumatic Brain Injury
ProTECT: Single Center, Phase II (Pilot), Double Blind, 4:1 Randomized, Placebo Controlled Clinical Trial for Progesterone Treatment of Moderate and Severe Blunt TBI

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Traumatic Brain Injury
Drug: IV Progesterone
  • Placebo Comparator: placebo
    placebo
    Intervention: Drug: IV Progesterone
  • Experimental: IV progesterone
    IV progesterone
    Intervention: Drug: IV Progesterone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00048646
0433-2001, 1 R01 NS-39097-01A1
Yes
David Wright, Emory University
David Wright
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Arthur L Kellermann, MD, MPH Chairman - Emory University Dept. of Emergency Medicine
Emory University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP