Brain Injury Biomarkers in the General Population

Brain Injuries, Traumatic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01786460
• Other study ID #: ATO-05
• Status: Completed
• Phase: N/A
• First received: February 6, 2013
• Last updated: January 30, 2017
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: January 2017
• Source: Banyan Biomarkers, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic

Intervention

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

Locations

Country	Name	City	State
United States	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	Gwinnett Medical Center	Lawrenceville	Georgia
United States	Office of Nagi S. Ibrahim	Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Banyan Biomarkers, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the putative biomarkers for TBI markers in general population using an investigational assay		up to 21 days
Secondary	Correlation of the putative biomarkers for TBI levels in general population to levels in patients with severe TBI		0, 14, 7, and 21 days