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

• ClinicalTrials.gov Identifier: NCT01426919
• Recruitment Status: Completed
• First Posted: September 1, 2011
• Last Update Posted: December 16, 2020
• Sponsor: Banyan Biomarkers, Inc
• Collaborator: United States Department of Defense
• Information provided by (Responsible Party): Banyan Biomarkers, Inc

Tracking Information

• First Submitted Date: August 30, 2011
• First Posted Date: September 1, 2011
• Last Update Posted Date: December 16, 2020
• Study Start Date: December 2012
• Actual Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 21, 2012): Correlation of assay result with absence of acute intracranial lesions [ Time Frame: Day 1 ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Biomarkers of Traumatic Brain Injury
• Official Title: A Prospective Clinical Evaluation of Biomarkers of Traumatic Brain Injury
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Traumatic Brain Injury
• Intervention: Other: Head CT scan and blood draw within 12 hours of injury

Study Groups/Cohorts

Suspected traumatic brain injury with head CT

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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 3, 2014): 2011
• Original Estimated Enrollment (submitted: August 31, 2011): 1650
• Actual Study Completion Date: July 2017
• Actual Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, Hungary, United States

Administrative Information

• NCT Number: NCT01426919
• Other Study ID Numbers: ATO-06
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Banyan Biomarkers, Inc
• Original Responsible Party: Same as current
• Current Study Sponsor: Banyan Biomarkers, Inc
• Original Study Sponsor: Same as current
• Collaborators: United States Department of Defense
• Investigators: Not Provided
• PRS Account: Banyan Biomarkers, Inc
• Verification Date: December 2020