Evaluation of Biomarkers of Traumatic Brain Injury (ALERT-TBI)

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Other: Head CT scan and blood draw within 12 hours of injury

• Study Type: Observational
• Enrollment (Actual): 2011

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, D-12200
    • Charité Universitätsmedizin Berlin - Campus Benjamin Franklin
  • Berlin, Germany, D-13353
    • Charité Universitätsmedizin Berlin - Campus Virchow Klinikum
  • Heidelberg, Germany, DE-69120
    • University of Heidelberg
  • Munich, Germany, DE-80336
    • Ludwig-Maximilians-University
  • Munich, Germany, DE-81675
    • Klinikum rechts der Isar of the Technical University of Munich
• Hungary
  • Pecs, Hungary, 7623
    • University of Pecs
  • Szeged, Hungary, 6725
    • University of Szeged, Albert Szent Gyorgi Medical Center
• United States
  • California
    • San Diego, California, United States, 92103
      • University of California San Diego
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Neurological Clinic
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School
  • Michigan
    • Detroit, Michigan, United States, 48235
      • Wayne State University - Sinai Grace Hospital
    • Detroit, Michigan, United States, 48201
      • Wayne State University - Detroit Receiving Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina at Chapel Hill
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh
  • Texas
    • Austin, Texas, United States, 78701
      • University Medical Center Brackenridge
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine/Ben Taub General Hospital
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia
    • Christiansburg, Virginia, United States, 24073
      • Carilion New River Valley
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected traumatic brain injury with head CT	Other: Head CT scan and blood draw within 12 hours of injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation of assay result with absence of acute intracranial lesions	Day 1

Collaborators and Investigators

• Sponsor: Banyan Biomarkers, Inc
• Collaborators: United States Department of Defense

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: August 30, 2011
• First Submitted That Met QC Criteria: August 31, 2011
• First Posted (ESTIMATE): September 1, 2011

Study Record Updates

• Last Update Posted (ACTUAL): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Traumatic Brain Injury; Head Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: ATO-06