Blood Collection of Patient Presenting in the ED and Pres... | NCT02614209

Studies
Blood Collection of Patient Presenting in the ED and Prescribed a BNP

NCT02614209

Sponsor

Fujirebio Diagnostics, Inc.

Status

Completed

Last Update Posted

Aug 10, 2016Estimated

Enrollment

400Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

In Vitro diagnostic tests

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

Nov 2015

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

May 2015

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Nov 6, 2015

First Submission Date that Met QC Criteria

Nov 24, 2015

First Posted Date

Nov 25, 2015Estimated

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

Aug 9, 2016

Last Update Posted Date

Aug 10, 2016Estimated

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

Plasma specimen collected from patients presenting in the Emergency Department (ED) with or without Heart Failure (HF) and prescribed a BNP.

Detailed Description

Plasma samples are collected from a minimum of 400 subjects. Specimens are used to confirm the currently accepted BNP cut off as and aid in the diagnosis and assessment of HF.

Stored specimens for future use in BNP assay development.

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

400Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
In Vitro diagnostic tests	Device	Prospective blood collection		Propective collection for use in InVitro diagnostic studies

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measure BNP	400 subjects	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males and females >21 years of age
Able to understand and willing to provide informed consent
Present in to ED
BNP test requested

Exclusion Criteria:

Males and females< 21 years
Unable to provide informed consent
Not presenting to ED
hemolyzed sample

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients presenting to ED and prescribed a BNP with or without HF

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Diana Dickson, RAC	Fujirebio Diagnostics, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Maryland		Baltimore	Maryland	21201	United States
Henry Ford Health System

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided