EVALUATION OF BIOMARKERS OF TRAUMATIC BRAIN INJURY EXTENSION STUDY

NCT ID: NCT02439736

Last Updated: 2017-08-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 119 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-11-30

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).

Conditions

Traumatic Brain Injury

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CT positive for acute intracranial lesion

Blood draw within 12 hours of head injury

Intervention Type: OTHER

Interventions

Blood draw within 12 hours of head injury

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Banyan Biomarkers, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

University of Virginia

Charlottesville, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Ludwig-Maximilians-University

Munich, , Germany

Klinikum rechts der Isar of the Technical University of Munich

Munich, , Germany

Countries

United States; Germany

Other Identifiers

ATO-06x

Identifier Type: -

Identifier Source: org_study_id