HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma

Summary

Participation Requirements

Description

This study proposes to collect data using a multi-modality approach including blood biomarkers, clinical assessments, neurocognitive performance, and neuropsychological characteristics, to identify subjects with a mild Traumatic Brain Injury (TBI) and their likelihood of chronic symptoms. This is an...

This study proposes to collect data using a multi-modality approach including blood biomarkers, clinical assessments, neurocognitive performance, and neuropsychological characteristics, to identify subjects with a mild Traumatic Brain Injury (TBI) and their likelihood of chronic symptoms. This is an observational study with an expectation of enrolling up to 2000 subjects. These subjects will include the intended use population, subjects presenting to the Emergency Department or Urgent Care with a blunt head trauma. Data will be collected across four time points, T=0, 14 days, 30 days and 90 days, to allow for building and validating the algorithms for both diagnosis and prognosis claims. Control populations, healthy and trauma only (no head trauma) will be included for assay development. Data will be collected for these groups at T=0 and 14 days (trauma control only).

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