Brain Injury Biomarkers in the General Population | NCT01786460

Studies
Brain Injury Biomarkers in the General Population

NCT01786460

Sponsor

Banyan Biomarkers, Inc

Status

Completed

Last Update Posted

Jan 31, 2017Estimated

Enrollment

800Actual

Phase

Not provided

Conditions

Brain Injuries, Traumatic

Interventions

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

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Feb 6, 2013

First Submission Date that Met QC Criteria

Feb 7, 2013

First Posted Date

Feb 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 30, 2017

Last Update Posted Date

Jan 31, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

800Actual

Label	Type	Description	Intervention Names
Healthy Volunteers			Other: Blood draw at Days 0, 7, 14, and 21

Name	Type	Description	Arm Group Labels	Other Names
Blood draw at Days 0, 7, 14, and 21	Other		Healthy Volunteers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assessment of the putative biomarkers for TBI markers in general population using an investigational assay		up to 21 days

Secondary Outcomes

Measure	Description	Time Frame
Correlation of the putative biomarkers for TBI levels in general population to levels in patients with severe TBI		0, 14, 7, and 21 days

Other Outcomes

Not provided

Eligibility Module

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:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers who meet eligibility criteria

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jackson Streeter, MD	Banyan Biomarkers	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Office of Nagi S. Ibrahim		Vista	California	92083	United States
Shands at University Florida Gainesville

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided