Blood samples will be drawn on traumatic brain injury patients who are participating in the
ProTECT III study.
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01730443
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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 -
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
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,
undocumented immigrants, or high likelihood of becoming incarcerated during study period, etc.)
Patient in Opt Out registry or wearing Opt Out bracelet -
All locations for NCT01730443
United States (37)
Banner Good Samaritan Health Center
Phoenix, Arizona, United States, 85006
Maricopa Integrated Health System
Phoenix, Arizona, United States, 85008
Phoenix, Arizona, United States, 85251
University of Arizona
Tucson, Arizona, United States, 85724
Stanford Medical Center
Palo Alto, California, United States, 94305
San Francisco General Hospital
San Francisco, California, United States, 94110
Regional Medical Ctr.-San Jose
San Jose, California, United States, 95116
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
University of Kentucky Hospital
Lexington, Kentucky, United States, 40536
University of Maryland Shock Trauma
Baltimore, Maryland, United States, 21201
Baltimore, Maryland, United States, 21287
Detroit, Michigan, United States, 48201
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sinai Grace Hospital
Detroit, Michigan, United States, 48235
Hurley Medical Center
Flint, Michigan, United States, 48503
Beaumont Health System
Royal Oak, Michigan, United States, 48073
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
North Memorial Hospital
Robbinsdale, Minnesota, United States, 55422
Regions Medical Center
St. Paul, Minnesota, United States, 55101
St. Johns Mercy Medical Center
St. Louis, Missouri, United States, 63141
New York, New York, United States, 10032
Cincinnati, Ohio, United States, 45267
Oregon Health Sciences University
Portland, Oregon, United States, 97239
St. Lukes Hospital
Bethlehem, Pennsylvania, United States, 18015
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
Philadelphia, Pennsylvania, United States, 19107
Philadelphia, Pennsylvania, United States, 19122
Regional Medical Center/Elvis Presley Memorial Trauma Center
Memphis, Tennessee, United States, 38103
Austin, Texas, United States, 78752
Memorial Hermann Hospital
Houston, Texas, United States, 77030
Brooke Army Medical Center
San Antonio, Texas, United States, 78234
Richmond, Virginia, United States, 23298
Froederdt Memorial Hospital
Milwaukee, Wisconsin, United States, 53226
View full eligibility
Tris trial is registered with FDA with number: NCT01730443. The sponsor of the trial is Emory University and it is looking for 576 volunteers for the current phase.
Official trial title: Biomarkers of Injury and Outcome in ProTECT III (BIO-ProTECT)
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