High-Shear Microfluidic Thrombosis Assay

Completed

• Conditions: Coagulation Defects, Other and Unspecified

• Registration Number: NCT02422810
• Lead Sponsor: Emory University

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.

Study Timeline

• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-17
• Study First Posted: 2015-04-21
• Study Start: 2015-05
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thrombotic occlusion time	30 minutes	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.

Trial Locations

Locations (1)

Emory Clinic; 🇺🇸 Atlanta, Georgia, United States