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NCT01426919 Clinical Trial

Evaluation of Biomarkers of Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— ALERT-TBI  

Official title:
A Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01426919
Other study ID # ATO-06
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2012
Est. completion date July 2017

Study information
Verified date December 2020
Source Banyan Biomarkers, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2011
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Head CT scan and blood draw within 12 hours of injury

Locations
Country Name City State
Germany Charité Universitätsmedizin Berlin - Campus Benjamin Franklin Berlin
Germany Charité Universitätsmedizin Berlin - Campus Virchow Klinikum Berlin
Germany University of Heidelberg Heidelberg
Germany Klinikum rechts der Isar of the Technical University of Munich Munich
Germany Ludwig-Maximilians-University Munich
Hungary University of Pecs Pecs
Hungary University of Szeged, Albert Szent Gyorgi Medical Center Szeged
United States University Medical Center Brackenridge Austin Texas
United States University of North Carolina at Chapel Hill Chapel Hill North Carolina
United States University of Virginia Charlottesville Virginia
United States Carilion New River Valley Christiansburg Virginia
United States Wayne State University - Detroit Receiving Hospital Detroit Michigan
United States Wayne State University - Sinai Grace Hospital Detroit Michigan
United States University of Florida Gainesville Florida
United States Hartford Hospital Hartford Connecticut
United States Baylor College of Medicine/Ben Taub General Hospital Houston Texas
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Virginia Commonwealth University Richmond Virginia
United States University of Rochester Medical Center Rochester New York
United States Washington University Saint Louis Missouri
United States University of California San Diego San Diego California
United States University of Washington Seattle Washington
United States Tallahassee Neurological Clinic Tallahassee Florida
United States University of Massachusetts Medical School Worcester Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Banyan Biomarkers, Inc United States Department of Defense

Countries where clinical trial is conducted

United States,  Germany,  Hungary, 

References & Publications (2)

Bazarian JJ, Biberthaler P, Welch RD, Lewis LM, Barzo P, Bogner-Flatz V, Gunnar Brolinson P, Büki 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, — View 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. Erratum in: J Appl Lab Med. 2020 May 1;5(3):608. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of assay result with absence of acute intracranial lesions Day 1
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