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 |
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.
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
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Univ of Massachusetts Med School As the commonwealth's only public medical school, we take seriously...
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