Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2011 participants
OBSERVATIONAL
2012-12-31
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Suspected traumatic brain injury with head CT
Head CT scan and blood draw within 12 hours of injury
Interventions
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Head CT scan and blood draw within 12 hours of injury
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Banyan Biomarkers, Inc
INDUSTRY
Responsible Party
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Locations
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University of California San Diego
San Diego, California, United States
Hartford Hospital
Hartford, Connecticut, United States
University of Florida
Gainesville, Florida, United States
Tallahassee Neurological Clinic
Tallahassee, Florida, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
Wayne State University - Detroit Receiving Hospital
Detroit, Michigan, United States
Wayne State University - Sinai Grace Hospital
Detroit, Michigan, United States
Washington University
St Louis, Missouri, United States
University of Rochester Medical Center
Rochester, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
University Medical Center Brackenridge
Austin, Texas, United States
Baylor College of Medicine/Ben Taub General Hospital
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Carilion New River Valley
Christiansburg, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Washington
Seattle, Washington, United States
Charité Universitätsmedizin Berlin - Campus Benjamin Franklin
Berlin, , Germany
Charité Universitätsmedizin Berlin - Campus Virchow Klinikum
Berlin, , Germany
University of Heidelberg
Heidelberg, , Germany
Ludwig-Maximilians-University
Munich, , Germany
Klinikum rechts der Isar of the Technical University of Munich
Munich, , Germany
University of Pecs
Pécs, , Hungary
University of Szeged, Albert Szent Gyorgi Medical Center
Szeged, , Hungary
Countries
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References
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Ward MD, Weber A, Merrill VD, Welch RD, Bazarian JJ, Christenson RH. Predictive Performance of Traumatic Brain Injury Biomarkers in High-Risk Elderly Patients. J Appl Lab Med. 2020 Jan 1;5(1):91-100. doi: 10.1093/jalm.2019.031393.
Bazarian JJ, Biberthaler P, Welch RD, Lewis LM, Barzo P, Bogner-Flatz V, Gunnar Brolinson P, Buki A, Chen JY, Christenson RH, Hack D, Huff JS, Johar S, Jordan JD, Leidel BA, Lindner T, Ludington E, Okonkwo DO, Ornato J, Peacock WF, Schmidt K, Tyndall JA, Vossough A, Jagoda AS. Serum GFAP and UCH-L1 for prediction of absence of intracranial injuries on head CT (ALERT-TBI): a multicentre observational study. Lancet Neurol. 2018 Sep;17(9):782-789. doi: 10.1016/S1474-4422(18)30231-X. Epub 2018 Jul 24.
Bazarian JJ, Welch RD, Caudle K, Jeffrey CA, Chen JY, Chandran R, McCaw T, Datwyler SA, Zhang H, McQuiston B. Accuracy of a rapid glial fibrillary acidic protein/ubiquitin carboxyl-terminal hydrolase L1 test for the prediction of intracranial injuries on head computed tomography after mild traumatic brain injury. Acad Emerg Med. 2021 Nov;28(11):1308-1317. doi: 10.1111/acem.14366. Epub 2021 Sep 7.
Other Identifiers
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ATO-06
Identifier Type: -
Identifier Source: org_study_id