EVALUATION OF BIOMARKERS OF TRAUMATIC BRAIN INJURY EXTENSION STUDY

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Other: Blood draw within 12 hours of head injury

• Registration Number: NCT02439736
• Lead Sponsor: Banyan Biomarkers, Inc

Brief Summary

The primary objective of this study is to evaluate Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of CT-positive subjects (as determined by an independent Neuroimaging Review Committee) presenting acutely with traumatic brain injury (Glasgow Coma Scale score 9-15).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-12
• Study Start: 2015-06
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-07
• Last Update Posted: 2017-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

• The Subject is at least 18 years of age at screening.
• The Subject has presented to a Health Care Facility (HCF) or Emergency Department (ED) with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
• A Glasgow Coma Scale score of 9-15 at the time of Informed Consent.
• The subject is CT-positive for acute intracranial lesion(s) based on the local neuroradiologist's review of the subject's head CT scan.
• The CT scan and CT report used to determine eligibility must be available.
• The blood sample is collected as close to the time of head injury as possible, but no later than 12 hours.
• The Subject or their legal representative is willing to undergo the Informed Consent process prior to enrollment into this study

Exclusion Criteria

• Participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study would be acceptable).
• Time of injury cannot be determined.
• Primary diagnosis of ischemic or hemorrhagic stroke.
• Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., IV drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)).
• The subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.
• The subject has a history of neurosurgery within the last 30 days.
• Administration of blood transfusion after head injury and prior to the study blood draw.
• The subject is a female who is pregnant or lactating.
• The Subject is otherwise determined by the Investigator to be an unsuitable candidate for participation. If this criterion applies, a reason must be provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CT positive for acute intracranial lesion	Blood draw within 12 hours of head injury	-

Primary Outcome Measures

Name	Time	Method
Correlation of assay results with presence of acute intracranial lesions	Day 1

Trial Locations

Locations (7)

University of California San Diego; 🇺🇸 San Diego, California, United States

Wayne State University - Detroit Receiving Hospital; 🇺🇸 Detroit, Michigan, United States

Baylor College of Medicine/Ben Taub General Hospital; 🇺🇸 Houston, Texas, United States

Klinikum rechts der Isar of the Technical University of Munich; 🇩🇪 Munich, Germany

Ludwig-Maximilians-University; 🇩🇪 Munich, Germany

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States