Trials / Completed
CompletedNCT02541123
Evaluation of Biomarker Kinetics After Mild Brain Injury Trauma
A Prospective Evaluation of Uch-l1 and Gfap Biomarker Kinetics After Mild Brain Injury Trauma
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 194 (actual)
- Sponsor
- Banyan Biomarkers, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2017-02-28
- Completion
- 2017-02-28
- First posted
- 2015-09-04
- Last updated
- 2020-12-16
Locations
10 sites across 3 countries: United States, Germany, Hungary
Source: ClinicalTrials.gov record NCT02541123. Inclusion in this directory is not an endorsement.