Evaluation of Biomarkers of Mild, Moderate and Severe Traumatic Brain Injury (ALERT)

Principal Investigators

Dr. Jeffrey J. Bazarian

Introduction

Traumatic Brain Injury (TBI) is a significant health problem representing a potentially catastrophic and debilitating medical emergency. Accurate diagnosis of combat-inflicted traumatic brain injury (TBI) is a major concern for the military. Experience from the Afghanistan and Iraqi theaters suggests TBIs may result from exposure to explosive blasts. In fact TBI has been called the "signature injury" of these conflicts. Many of these suspected TBIs go undiagnosed resulting in impairment of combat and duty performance, as well as profound and persistent impairment of physical, cognitive, and psychosocial functioning. It is essential to diagnose a TBI at the time of injury so that individuals can be removed from active duty and receive appropriate care. Additionally, since the symptoms of PCS are similar to those of post-traumatic stress disorder (PTSD), and these two conditions often occur concurrently, a definitive diagnosis of TBI is essential for recognition and treatment of each disorder.

Purpose

The primary objective of this clinical trial is to evaluate the utility of the Banyan Biomarkers Test in traumatic brain injury detection. The trial will evaluate the utility of the assay for detecting TBI in subjects with known disease status.

Design Methods

This is a prospective, open label, global, multi-center FDA clinical trial. Quantitative serum-based TBI biomarkers and qualitative neurocoginitve assessments will be used to ascertain if there is a correlation with mild and/or moderate TBI.

Significance of the study

Development of valid biomarkers for TBI will have a major impact on diagnosis, management and treatment of brain injured patients.  Accurate diagnosis in acute care environments can significantly simplify decisions about patient management including whether to admit, discharge, or the need to administer other time consuming, expensive, and often inaccurate diagnostic tests such as computed tomography (CT) and magnetic resonance imaging (MRI) scans. Banyan Biomarkers, Inc. (Carlsbad, CA) has developed this in vitro quantitative serum/plasma test that combines the results of immunoassays into a single numerical score. The test is to be used, in conjunction with standard clinical assessment, as an aid in the diagnosis of traumatic brain injury. Simple, rapid diagnostic tools will immensely facilitate allocation of the major medical resources required to treat brain injuries.