Clinical trial NCT01426919: Evaluation of Biomarkers of Traumatic Brain Injury
Official title: A Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Head Injury
Lead sponsor: Banyan Biomarkers, Inc
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2011-09-01
Enrollment: 2011
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects eligible for study participation will be over the age of 18 and present to the health care facility with a head injury at a time such that sample collection can be completed within 12 hours of injury. Subjects who will be permitted into the study include those who will meet all the inclusion criteria and will have none of the exclusion criteria.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Correlation of assay result with absence of acute intracranial lesions
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University - Detroit Receiving Hospital
state: Michigan
city: Detroit
country: United States
facility: Wayne State University - Sinai Grace Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Austin
country: United States
facility: University Medical Center Brackenridge
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/Ben Taub General Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Christiansburg
country: United States
facility: Carilion New River Valley
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin - Campus Benjamin Franklin
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin - Campus Virchow Klinikum
city: Heidelberg
country: Germany
facility: University of Heidelberg
city: Munich
country: Germany
facility: Ludwig-Maximilians-University
city: Munich
country: Germany
facility: Klinikum rechts der Isar of the Technical University of Munich
city: Pecs
country: Hungary
facility: University of Pecs
city: Szeged
country: Hungary
facility: University of Szeged, Albert Szent Gyorgi Medical Center
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.