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CompletedNCT01786460Updated Jan 31, 2017

Brain Injury Biomarkers in the General Population

An observational study in Brain Injuries, Traumatic, sponsored by Banyan Biomarkers, Inc. Completed at 5 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-01-31.

Sponsored by Banyan Biomarkers, Inc · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
800
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Brain Injuries, Traumatic
03

In context

Brain Injuries

2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.

This study's enrollment of 800 is above the median of 100 across 690 observational studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

Banyan Biomarkers, Inc is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy volunteers who meet eligibility criteria

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
800 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Healthy Volunteers

    Other: Blood draw at Days 0, 7, 14, and 21

Interventions

  • OtherBlood draw at Days 0, 7, 14, and 21
06

What researchers measure

Primary outcomes

  1. Assessment of the putative biomarkers for TBI markers in general population using an investigational assay

    Time frame: up to 21 days

Secondary outcomes

  1. Correlation of the putative biomarkers for TBI levels in general population to levels in patients with severe TBI

    Time frame: 0, 14, 7, and 21 days

07

Study locations

5 sites
  • Office of Nagi S. Ibrahim
    Vista, California 92083, United States
  • Shands at University Florida Gainesville
    Gainesville, Florida 32610, United States
  • Dekalb Medical Center
    Decatur, Georgia 30033, United States
  • Gwinnett Medical Center
    Lawrenceville, Georgia 30045, United States
  • New England Center for Clinical Research
    Fall River, Massachusetts 02720, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01786460
Lead sponsor
Banyan Biomarkers, Inc
Responsible party
Sponsor
First posted
Feb 8, 2013
Start date
Jan 2011
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Jan 31, 2017

Study contacts

Jackson Streeter, MD
study chair · Banyan Biomarkers

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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