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
  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
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • neurological outcome [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    GOS, DRS, and GOAT


Enrollment: 100
Study Start Date: May 2002
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo
Drug: IV Progesterone
Experimental: IV progesterone
IV progesterone
Drug: IV Progesterone

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
David Wright
Investigators
Principal Investigator: Arthur L Kellermann, MD, MPH Chairman - Emory University Dept. of Emergency Medicine
  More Information

Publications:
Responsible Party: David Wright, Co-Investigator, Project Lead, Emory University
ClinicalTrials.gov Identifier: NCT00048646     History of Changes
Other Study ID Numbers: 0433-2001, 1 R01 NS-39097-01A1
Study First Received: November 4, 2002
Last Updated: September 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Keywords provided by Emory University:
TBI
ProTECT

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

ClinicalTrials.gov processed this record on August 19, 2014