Blood Biomarkers of Injury and Outcome in Traumatic Brain Injury

Stopped early

Conditions studied: Traumatic Brain Injury

In brief

Blood samples will be drawn on traumatic brain injury patients who are participating in the ProTECT III study.

Key facts

Study ID

NCT01730443

Run by

Emory University

People needed

576

Starts

2011-07-01

Expected to finish

2014-07-01

Last updated by the study team

2014-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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,
• undocumented immigrants, or high likelihood of becoming incarcerated during study period, etc.)
• Patient in Opt Out registry or wearing Opt Out bracelet -

Where it is running

• Banner Good Samaritan Health Center — Phoenix, Arizona, United States
• Maricopa Integrated Health System — Phoenix, Arizona, United States
• Scottsdale Healthcare — Phoenix, Arizona, United States
• University of Arizona — Tucson, Arizona, United States
• Stanford Medical Center — Palo Alto, California, United States
• San Francisco General Hospital — San Francisco, California, United States
• Regional Medical Ctr.-San Jose — San Jose, California, United States
• Santa Clara Valley Medical Center — San Jose, California, United States
• Grady Memorial Hospital — Atlanta, Georgia, United States
• University of Kentucky Hospital — Lexington, Kentucky, United States
• University of Maryland Shock Trauma — Baltimore, Maryland, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Detroit Receiving — 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 Health System — Royal Oak, Michigan, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• North Memorial Hospital — Robbinsdale, Minnesota, United States
• Regions Medical Center — Saint Paul, Minnesota, United States
• St. Johns Mercy Medical Center — St Louis, Missouri, United States
• NYP Columbia — New York, New York, United States
• University Hospital — Cincinnati, Ohio, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• St. Lukes Hospital — Bethlehem, Pennsylvania, United States

Full record on ClinicalTrials.gov

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