Progesterone for the Treatment of Traumatic Brain Injury (ProTECT III)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
David Wright, Emory University
ClinicalTrials.gov Identifier:
NCT00822900
First received: January 14, 2009
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

The ProTECT study will determine if intravenous (IV) progesterone (started within 4 hours of injury and given for a total of 96 hours), is more effective than placebo for treating victims of moderate to severe acute traumatic brain injury.


Condition Intervention Phase
Traumatic Brain Injury
Drug: Progesterone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Clinical Trial to Determine if Progesterone Along With Standard Medical Care for Brain Injury is More Effective at Limiting the Amount of Damage Cause by a Traumatic Brain Injury Than Standard Medical Care Alone.

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Progesterone will significantly increase the proportion of patients with a favorable outcome as determined by the Glasgow Outcome Scale-Extended (GOSE) score at 6 months post injury when compared to placebo. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death; Disability Rating Scale; cognitive, neurological, functional outcomes; and rates of adverse events will be examined in moderate to severe traumatic brain injury patients who received either IV progesterone or placebo. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1140
Study Start Date: March 2010
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Progesterone
Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone or placebo) will be administered as a continuous intravenous infusion at 0.5 mg/kg/hr for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 72 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone/placebo will be combined with a 20% Intralipid mixture for infusion.
Drug: Progesterone
Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone or placebo) will be administered as a continuous intravenous infusion at 0.5 mg/kg/hr for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table will be used by the on-sight pharmacy to mix the correct dose for a 10 cc/hour continuous infusion over the 71 hour steady state period followed by three additional 8-hour decrements (7.5 cc/hr-5.0 cc/hr-2.5 cc/hr) to zero, for a total treatment duration of 96 hour. The progesterone/placebo will be combined with a 20% Intralipid mixture for infusion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe brain injury (GCS 12-4)
  • Age 18 years or older
  • Blunt, closed head injury
  • Arrival < 4 hours from injury

Exclusion Criteria:

  • Non-Survivable injury
  • Bilateral dilated unresponsive pupils
  • Severe intoxication (ETOH > 250 mg %)
  • Spinal cord injury with neurological deficits
  • Inability to perform activities of daily living prior to injury
  • Cardiopulmonary arrest
  • Status epilepticus on arrival
  • Systolic blood pressure (SBP) < 90 on arrival or for at least 5 minutes prior to enrollment
  • O2 Sat < 90 on arrival or for at least 5 minutes prior to enrollment
  • Prisoner or ward of state
  • Pregnant
  • Active breast or reproductive organ cancers
  • Known allergy to progesterone or intralipid components (egg yolk)
  • Known history of clotting disorder
  • Active thromboembolic event
  • Concern for inability to follow up at 6 months
  • Anyone listed in the Opt out registry
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822900

  Hide Study Locations
Locations
United States, Arizona
Maricopa Integrated Health System
Phoenix, Arizona, United States, 85008
Banner Good Samaritan
Phoenix, Arizona, United States
Scottsdale Healthcare
Scottsdale, Arizona, United States
University of Arizona Medical Center
Tuscon, Arizona, United States, 85724
United States, California
Stanford Medical Center
Palo Alto, California, United States, 94304
Santa Clara Valley Hospital
Palo Alto, California, United States, 94304
San Francisco General Hospital
San Francisco, California, United States, 94110
Regional Medical Center-San Jose
San Jose, California, United States
United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
United States, Maryland
University of Maryland Shock Trauma
Baltimore, Maryland, United States, 21201
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Detroit Receiving Hospital
Detroit, Michigan, United States, 48202
Sinai Grace Hospital
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States, 48503
Beaumont Royal Oak Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55414
North Memorial Hospital
Robbinsdale, Minnesota, United States
Regions Hospital
St. Paul, Minnesota, United States, 55101
United States, Missouri
St. Johns Mercy Medical Center
St. Louis, Missouri, United States, 63141
United States, New York
Columbia New York Presbyterian Hospital
New York, New York, United States, 10032
United States, Ohio
University Hospital
Cincinnatti, Ohio, United States, 45267
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
St. Luke's Hospital
Bethlehem, Pennsylvania, United States, 18017
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson UniversityHospital
Philadelphia, Pennsylvania, United States, 19107
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
United States, Tennessee
Regional Medical Center/Elvis Presley Memorial Trauma Center (The MED)
Memphis, Tennessee, United States
United States, Texas
Austin/Brackenridge
Austin, Texas, United States, 78752
Memorial Hermann
Houston, Texas, United States, 77030
Brooke Army Medical Center
San Antonio, Texas, United States
United States, Virginia
Virginia Commonwealth
Richmond, Virginia, United States, 23298
United States, Wisconsin
Froedtert East Hospital
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
David Wright
Investigators
Principal Investigator: David W Wright, MD Emory University
  More Information

Additional Information:
No publications provided

Responsible Party: David Wright, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00822900     History of Changes
Other Study ID Numbers: IRB00014409, 1RO1 NS062778-01
Study First Received: January 14, 2009
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
Trauma
Brain Injury

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 April 17, 2014