Evaluation of Biomarkers of Traumatic Brain Injury



Status:Completed
Conditions:Hospital, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:8/9/2017
Start Date:December 2012
End Date:July 2017

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A Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury

The primary objective of this study is to evaluate the utility of the Banyan UCH-L1/GFAP
Detection Assay as an aid in the evaluation of suspected traumatic brain injury (Glasgow Coma
Scale score 9-15) in conjunction with other clinical information within 12 hours of injury to
assist in determining the need for a CT scan of the head.


Inclusion Criteria:

- subject is at least 18 years of age at screening

- suspected traumatically induced head injury as a result of insult to the head from
external force

- GCS 9-15 at time of informed consent

- workup includes head CT scan as part of clinical emergency care within 3 hours of
presenting and within 12 hours of injury

- blood sample collected within 3 hours of presenting and within 12 hours of injury

- subject or legal representative is willing to undergo informed consent

Exclusion Criteria:

- participating in an interventional, therapeutic clinical study that may affect the
results of this study (an observational study acceptable)

- time of injury cannot be determined

- primary diagnosis of ischemic or hemorrhagic stroke

- venipuncture not feasible

- a condition precluding entry into the CT scanner

- subject has a neurodegenerative disease or other neurological disorder including
dementia, Parkinson's disease, multiple sclerosis, seizure disorder, brain tumors, and
history of neurosurgery, stroke or TIA within the last 30 days

- administration of blood transfusion after head injury and prior to study blood draw

- subject is otherwise determined by the Investigator to be unsuitable for participation
We found this trial at
18
sites
Tallahassee, Florida 32308
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Chapel Hill, NC
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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Austin, TX
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Berlin,
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Charlottesville, VA
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Christiansburg, Virginia 24073
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Christiansburg, VA
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Detroit, MI
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Detroit, MI
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Hartford, CT
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Houston, TX
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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Saint Louis, Missouri 63110
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Saint Louis, MO
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San Diego, California 92093
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San Diego, CA
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55 N Lake Ave
Worcester, Massachusetts 01655
(508) 856-8989
Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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Worcester, MA
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