Clinical trial NCT00822900: Progesterone for the Treatment of Traumatic Brain Injury III
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Traumatic Brain Injury
Keywords: Trauma
Brain Injury
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Medical University of South Carolina
name: Neurological Emergencies Treatment Trials Network (NETT)
First posted: 2009-01-15
Enrollment: 882
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Moderate to severe brain injury (GCS 12-4)
* Age 18 years or older
* Blunt, closed head injury
* Study drug initiated within 4 hours of 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

Primary outcomes:
measure: Favorable Outcome as Determined by the Glasgow Outcome Scale-Extended (GOSE)
timeFrame: 6 months post randomization
Secondary outcomes:
measure: Mortality
timeFrame: 6 months
measure: Disability Rating Scale
timeFrame: 6 months
measure: Potentially Associated Adverse Events: Phlebitis/Thrombophlebitis
timeFrame: within 6 months
measure: Potentially Associated Adverse Events: Pulmonary Embolism
timeFrame: within 6 months
measure: Potentially Associated Adverse Events: Acute Ischemic Stroke
timeFrame: within 6 months
measure: Potentially Associated Adverse Events: Deep Venous Thrombosis (DVT)
timeFrame: within 6 months
measure: Potentially Associated Adverse Events: Unexplained Increased Liver-enzyme Level
timeFrame: within 6 months
measure: Potentially Associated Adverse Events: Sepsis
timeFrame: within 6 months
measure: Potentially Associated Adverse Events: Pneumonia
timeFrame: within 6 months
measure: Potentially Associated Adverse Events: Central Nervous System (CNS) Infection
timeFrame: within 6 months
measure: Potentially Associated Adverse Events: Myocardial Infarction (MI)
timeFrame: within 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Integrated Health System
state: Arizona
city: Phoenix
country: United States
facility: Banner Good Samaritan
state: Arizona
city: Scottsdale
country: United States
facility: Scottsdale Healthcare
state: Arizona
city: Tuscon
country: United States
facility: University of Arizona Medical Center
state: Arizona
city: Palo Alto
country: United States
facility: Santa Clara Valley Hospital
state: California
city: Palo Alto
country: United States
facility: Stanford Medical Center
state: California
city: San Francisco
country: United States
facility: San Francisco General Hospital
state: California
city: San Jose
country: United States
facility: Regional Medical Center-San Jose
state: California
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Baltimore
country: United States
facility: University of Maryland Shock Trauma
state: Maryland
city: Detroit
country: United States
facility: Detroit Receiving Hospital
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Detroit
country: United States
facility: Sinai Grace Hospital
state: Michigan
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Royal Oak Hospital
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Robbinsdale
country: United States
facility: North Memorial Hospital
state: Minnesota
city: St. Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: St. Louis
country: United States
facility: St. Johns Mercy Medical Center
state: Missouri
city: New York
country: United States
facility: Columbia New York Presbyterian Hospital
state: New York
city: Cincinnatti
country: United States
facility: University Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hahnemann University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson UniversityHospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Memphis
country: United States
facility: Regional Medical Center/Elvis Presley Memorial Trauma Center (The MED)
state: Tennessee
city: Austin
country: United States
facility: Austin/Brackenridge
state: Texas
city: Houston
country: United States
facility: Memorial Hermann
state: Texas
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert East Hospital
state: Wisconsin
Study officials:
affiliation: Emory University
name: David W Wright, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.