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Evaluation of Biomarker Kinetics After Mild Brain Injury Trauma

NCT02541123 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 194

Last updated 2020-12-16

No results posted yet for this study

Summary

The primary objective of the clinical trial is to evaluate the effect of time on levels of Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of head injured subjects over the age of 18 presenting acutely with a Glasgow Coma Scale score 13-15 as well as in a group of uninjured control subjects.

Conditions

Interventions

OTHER

Blood draw

Initial draw followed by additional blood draws every 4 hours thereafter, up to 24 hours from the initial blood draw (not to exceed 7 blood draws). Follow up blood draw at Day 7. Control group only undergoes 2 blood draws 4 hours apart on Day 1.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Banyan Biomarkers, Inc

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • United States
  • Germany
  • Hungary

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02541123 on ClinicalTrials.gov