NCT01786460

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

February 6, 2013

Last Update Submit

January 30, 2017

Conditions

Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (1)

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

    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

    0, 14, 7, and 21 days

Study Arms (1)

Healthy Volunteers

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

Interventions

Blood draw at Days 0, 7, 14, and 21OTHER
Healthy Volunteers

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers who meet eligibility criteria

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Office of Nagi S. Ibrahim

Vista, California, 92083, United States

Location

Shands at University Florida Gainesville

Gainesville, Florida, 32610, United States

Location

Dekalb Medical Center

Decatur, Georgia, 30033, United States

Location

Gwinnett Medical Center

Lawrenceville, Georgia, 30045, United States

Location

New England Center for Clinical Research

Fall River, Massachusetts, 02720, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum, plasma

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jackson Streeter, MD

    Banyan Biomarkers

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2013

First Posted

February 8, 2013

Study Start

January 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

US(5)