Progesterone for the Treatment of Traumatic Brain Injury III
NCT ID: NCT00822900
Last Updated: 2016-01-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
882 participants
INTERVENTIONAL
2010-03-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Progesterone
Following a one hour loading dose of 0.714 mg/kg per infusion pump through a dedicated IV line, the study drug (progesterone) 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 will be combined with a 20% Intralipid mixture for infusion.
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.
Placebo
Placebo stock solution was the ethanol diluent required for dissolving progesterone. The volume of placebo to be mixed with intralipid was based on the same mg/kg/hr volume that would be required if PROG had been in the vial. Using an infusion pump through a dedicated IV line - a one hour "loading dose" of placebo plus intralipid was administered as a continuous intravenous infusion for 71 hours, then tapered over an additional 24 hours. To simplify the infusion protocol, a weight based dosing table was 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 placebo will be combined with a 20% Intralipid mixture for infusion.
Placebo
Placebo stock solution is the ethanol diluent required for dissolving progesterone. The volume of placebo to be mixed with intralipid is based on the mg/kg/hr volume. Using an infusion pump through a dedicated IV line - a one hour "loading dose" of placebo plus intralipid is administered as a continuous intravenous infusion for 71 hours, then tapered over an additional 24 hours.
Interventions
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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.
Placebo
Placebo stock solution is the ethanol diluent required for dissolving progesterone. The volume of placebo to be mixed with intralipid is based on the mg/kg/hr volume. Using an infusion pump through a dedicated IV line - a one hour "loading dose" of placebo plus intralipid is administered as a continuous intravenous infusion for 71 hours, then tapered over an additional 24 hours.
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
* Blunt, closed head injury
* Study drug initiated within 4 hours of injury
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Medical University of South Carolina
OTHER
Neurological Emergencies Treatment Trials Network (NETT)
NETWORK
David Wright
OTHER
Responsible Party
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David Wright
Principal Investigator
Principal Investigators
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David W Wright, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Maricopa Integrated Health System
Phoenix, Arizona, United States
Banner Good Samaritan
Phoenix, Arizona, United States
Scottsdale Healthcare
Scottsdale, Arizona, United States
University of Arizona Medical Center
Tuscon, Arizona, United States
Santa Clara Valley Hospital
Palo Alto, California, United States
Stanford Medical Center
Palo Alto, California, United States
San Francisco General Hospital
San Francisco, California, United States
Regional Medical Center-San Jose
San Jose, California, United States
Grady Memorial Hospital
Atlanta, Georgia, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
University of Maryland Shock Trauma
Baltimore, Maryland, United States
Detroit Receiving Hospital
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Sinai Grace Hospital
Detroit, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Beaumont Royal Oak Hospital
Royal Oak, Michigan, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
North Memorial Hospital
Robbinsdale, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
St. Johns Mercy Medical Center
St Louis, Missouri, United States
Columbia New York Presbyterian Hospital
New York, New York, United States
University Hospital
Cincinnatti, Ohio, United States
Oregon Health Sciences University
Portland, Oregon, United States
St. Luke's Hospital
Bethlehem, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Thomas Jefferson UniversityHospital
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Regional Medical Center/Elvis Presley Memorial Trauma Center (The MED)
Memphis, Tennessee, United States
Austin/Brackenridge
Austin, Texas, United States
Memorial Hermann
Houston, Texas, United States
Brooke Army Medical Center
San Antonio, Texas, United States
Virginia Commonwealth
Richmond, Virginia, United States
Froedtert East Hospital
Milwaukee, Wisconsin, United States
Countries
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References
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Zhao W, Pauls K. Architecture design of a generic centralized adjudication module integrated in a web-based clinical trial management system. Clin Trials. 2016 Apr;13(2):223-33. doi: 10.1177/1740774515611889. Epub 2015 Oct 13.
Wright DW, Yeatts SD, Silbergleit R, Palesch YY, Hertzberg VS, Frankel M, Goldstein FC, Caveney AF, Howlett-Smith H, Bengelink EM, Manley GT, Merck LH, Janis LS, Barsan WG; NETT Investigators. Very early administration of progesterone for acute traumatic brain injury. N Engl J Med. 2014 Dec 25;371(26):2457-66. doi: 10.1056/NEJMoa1404304. Epub 2014 Dec 10.
Other Identifiers
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1RO1 NS062778-01
Identifier Type: -
Identifier Source: secondary_id
IRB00014409
Identifier Type: -
Identifier Source: org_study_id
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