Brain Injury Biomarkers in the General Population
Completed
- Conditions
- Brain Injuries, Traumatic
- Interventions
- Other: Blood draw at Days 0, 7, 14, and 21
- Registration Number
- NCT01786460
- Lead Sponsor
- Banyan Biomarkers, Inc
- Brief Summary
The purpose of this study is to use an investigational assay to assess levels of putative biomarkers of traumatic brain injury (TBI) in a general population. The data will be used in a correlative analysis with data collected under a separate study of severe TBI.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
Inclusion Criteria
- At least 18 years of age and no more than 80 years of age
- Willing to undergo consent
- PI believes volunteer is appropriate candidate for study
Exclusion Criteria
- Participating in another clinical study that may affect the results of either study
- Non-English speaking
- Venipuncture not feasible
- Blood donation within 1 week of screening
- PI determines volunteer is not medically suitable for study participation
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Healthy Volunteers Blood draw at Days 0, 7, 14, and 21 -
- Primary Outcome Measures
Name Time Method Assessment of the putative biomarkers for TBI markers in general population using an investigational assay up to 21 days
- Secondary Outcome Measures
Name Time Method Correlation of the putative biomarkers for TBI levels in general population to levels in patients with severe TBI 0, 14, 7, and 21 days
Trial Locations
- Locations (5)
Dekalb Medical Center
🇺🇸Decatur, Georgia, United States
New England Center for Clinical Research
🇺🇸Fall River, Massachusetts, United States
Shands at University Florida Gainesville
🇺🇸Gainesville, Florida, United States
Office of Nagi S. Ibrahim
🇺🇸Vista, California, United States
Gwinnett Medical Center
🇺🇸Lawrenceville, Georgia, United States