Study Stopped
Parent trial (ProTECT III) stopped for futility
Blood Biomarkers of Injury and Outcome in Traumatic Brain Injury
BIO-ProTECT
Biomarkers of Injury and Outcome in ProTECT III (BIO-ProTECT)
2 other identifiers
observational
576
1 country
37
Brief Summary
Blood samples will be drawn on traumatic brain injury patients who are participating in the ProTECT III study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
Typical duration for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 26, 2011
CompletedFirst Posted
Study publicly available on registry
November 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedDecember 4, 2014
December 1, 2014
2.8 years
July 26, 2011
December 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
serum biomarkers of structural brain injury (S100B, glial fibrillary acid protein, ubiquitin carboxyl-terminal esterase L1, SBDP150) and progesterone levels will be measured.
Blood will be collected/processed at baseline, 24 hours and 48 hours.
Baseline, 24 hours, 48 hours
Study Arms (2)
On progesterone treatment
The group assigned to progesterone treatment.
group assigned to placebo
The group that will not be receiving progesterone treatment
Eligibility Criteria
patients with a moderate to severe blunt traumatic brain injury who meet the inclusion and exclusion criteria for the ProTECT III study.
You may qualify if:
- Moderate to severe brain injury (iGCS 12-4 or motor response 2-5 if intubated).
- Age \>18 years (or developmental stage Tanner 5 in patients where age is not known)
- Blunt, traumatic, closed head injury (altered mental status due to brain injury)
- Able to initiate study drug infusion within 4 hours from time of injury -
You may not qualify if:
- Non-survivable injury as determined by treating
- Bilateral dilated unresponsive pupils
- Spinal cord injury with neurological deficits, pre-injury paralysis (quad/paraplegic)
- Inability to perform activities of daily living (ADL) without assistance
- Cardiopulmonary arrest
- Status epilepticus on arrival or concern for post ictal state
- systolic blood pressure \< 90 for two consecutive readings at least 5 minutes apart any time prior to randomization
- O2 Sat \< 90 for at least 5 consecutive minutes any time prior to randomization
- Prisoner or ward of state
- Known active breast or reproductive organ cancers (via medical records or family interview)
- Known allergy to progesterone or Intralipid components (egg yolk) (via medical records or family interview)
- Known history of blood clotting disorder (Protein S or C deficiency, etc.) or history of pulmonary embolism (via medical records or family interview) or active/ongoing thromboembolic event (myocardial infarction, ischemic stroke, pulmonary embolism, deep vein thrombosis).
- Blood or serum ethanol (EtOH) ≥ 250 mg %
- Positive qualitative urine or serum pregnancy test
- Concern for inability to follow up at 6 months (residence in foreign country, homeless with limited contacts,
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Banner Good Samaritan Health Center
Phoenix, Arizona, 85006, United States
Maricopa Integrated Health System
Phoenix, Arizona, 85008, United States
Scottsdale Healthcare
Phoenix, Arizona, 85251, United States
University of Arizona
Tucson, Arizona, 85724, United States
Stanford Medical Center
Palo Alto, California, 94305, United States
San Francisco General Hospital
San Francisco, California, 94110, United States
Regional Medical Ctr.-San Jose
San Jose, California, 95116, United States
Santa Clara Valley Medical Center
San Jose, California, 95128, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
University of Kentucky Hospital
Lexington, Kentucky, 40536, United States
University of Maryland Shock Trauma
Baltimore, Maryland, 21201, United States
Johns Hopkins
Baltimore, Maryland, 21287, United States
Detroit Receiving
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Sinai Grace Hospital
Detroit, Michigan, 48235, United States
Hurley Medical Center
Flint, Michigan, 48503, United States
Beaumont Health System
Royal Oak, Michigan, 48073, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
North Memorial Hospital
Robbinsdale, Minnesota, 55422, United States
Regions Medical Center
Saint Paul, Minnesota, 55101, United States
St. Johns Mercy Medical Center
St Louis, Missouri, 63141, United States
NYP Columbia
New York, New York, 10032, United States
University Hospital
Cincinnati, Ohio, 45267, United States
Oregon Health Sciences University
Portland, Oregon, 97239, United States
St. Lukes Hospital
Bethlehem, Pennsylvania, 18015, United States
Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
Jefferson Hospital
Philadelphia, Pennsylvania, 19107, United States
Temple University
Philadelphia, Pennsylvania, 19122, United States
Regional Medical Center/Elvis Presley Memorial Trauma Center
Memphis, Tennessee, 38103, United States
Brackenridge Hospital
Austin, Texas, 78752, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
Brooke Army Medical Center
San Antonio, Texas, 78234, United States
Virginia Commonwealth
Richmond, Virginia, 23298, United States
Froederdt Memorial Hospital
Milwaukee, Wisconsin, 53226, United States
Biospecimen
with consent there will be long term storage of serum for Non-DNA testing
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Frankel, MD
Emory University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 26, 2011
First Posted
November 21, 2012
Study Start
July 1, 2011
Primary Completion
May 1, 2014
Study Completion
July 1, 2014
Last Updated
December 4, 2014
Record last verified: 2014-12