Evaluation of Biomarkers of Traumatic Brain Injury

Completed

Conditions studied: Traumatic Brain Injury

In brief

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.

Key facts

Study ID

NCT01426919

Run by

Banyan Biomarkers, Inc

People needed

2011

Starts

2012-12-01

Expected to finish

2017-07-01

Last updated by the study team

2020-12-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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