High-Shear Microfluidic Thrombosis Assay | NCT02422810

Studies
High-Shear Microfluidic Thrombosis Assay

NCT02422810

Sponsor

Emory University

Status

Completed

Last Update Posted

Jun 7, 2018Actual

Enrollment

16Actual

Phase

Not provided

Conditions

Coagulation Defects, Other and Unspecified

Interventions

Not provided

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

Jun 2018

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

Oct 2015Actual

Completion Date

Oct 2015Actual

First Submitted Date

Apr 17, 2015

First Submission Date that Met QC Criteria

Apr 17, 2015

First Posted Date

Apr 21, 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

Jun 5, 2018

Last Update Posted Date

Jun 7, 2018Actual

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 characterize a new test to assess the rate and time it takes to form a blood clot in people who either do or do not take aspirin.

Detailed Description

It is estimated that approximately 25% of people are resistant to aspirin, or do not respond to its effect. These individuals have a four fold higher risk of a heart attack or stroke compared to those who respond to aspirin. Current tests for determining those who are aspirin resistant are not reliable. This study is assessing the effectiveness of a new assay in determining the rate and time it takes for people who are or are not on aspirin in forming a blood clot.

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

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No aspirin		Subjects who have not taken aspirin or other blood thinners in the previous 10 days
Aspirin Daily		Subjects who have taken aspirin daily for the previous 10 or more days
New to aspirin		Subjects newly started on aspirin during their visit

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Thrombotic occlusion time	A microfluidic assay will be used to assess thrombus formation induced by exposed collagen within a stenosis that induces high shear rates. The amount of time taken to completely occlude an aperture is called the thrombotic occlusion time.	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria for "no aspirin" group:

have not taken aspirin, other nonsteroidal anti-inflammatory drugs (NSAIDs), or clopidogrel in the previous 10 days
no history of myocardial infarction, ischemic stroke, or other ischemic event

Inclusion Criteria for "aspirin daily" group:

have taken aspirin daily over the last 10 days or more
no history of myocardial infarction, ischemic stroke, or other ischemic event

Inclusion Criteria for "new to aspirin" group:

have not previously been prescribed aspirin, but have been prescribed aspirin at their present appointment, e.g. a high calcium plaque score on CT
no history of myocardial infarction, ischemic stroke, or other ischemic event

Exclusion Criteria:

a known bleeding or thrombotic disorder

Exclusion Criteria for "new to aspirin" group:

a known bleeding or thrombotic disorder
have taken aspirin, other NSAIDs, clopidogrel, or an anticoagulant in the previous 10 days

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects are healthy Emory Executive Health patients over the age of 45 with no history of myocardial infarction, ischemic stroke, or other ischemic event

Sampling Method

Probability Sample

Name	Affiliation	Role
Sharon Bergquist, MD	Emory University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Emory Clinic		Atlanta	Georgia	30322	United States

Condition Browse Module

MeSH Terms

ID	Term
D020141	Hemostatic Disorders

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006474	Hemorrhagic Disorders
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided