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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

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