Clinical Performance of Investigational InRhythm PT/INR System in a Professional Use Setting

NCT ID: NCT02586818

Last Updated: 2021-08-30

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL

Brief Summary

This study is designed to evaluate and verify the clinical accuracy of the InRhythm PT/INR system; a point-of-care, whole blood PT/INR measurement with a reference plasma based PT/INR using a laboratory reference instrument and reagent (Sysmex/lnnovin) calibrated to the WHO rTF09 reference standard.

Conditions

Blood Dyscrasia

Eligibility Criteria

Inclusion Criteria

• The subjects must be > 18 years of age.
• The subjects must be willing and competent to sign an informed consent.
• The subjects must be able to attend the clinic for one visit to donate one FS blood sample and one venous blood draw of approximately 10 cc.

• The subject must require oral VKA anticoagulant therapy.
• The patient must have been anticoagulated for at least three months prior to enrollment.

Exclusion Criteria

• The subject is unable to donate fingerstick and venous blood samples.
• The subject has a history of clinically significant bleeding associated with incising the finger and/or the venipuncture.
• The subject is enrolled in any other study that involves an investigational drug and/or device.

• Subjects receiving any form of anticoagulation drugs such as Aspirin or Clopidogrel.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: collaborator

Accriva Diagnostics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

INR_CSP_015_0002_RA

Identifier Type: -

Identifier Source: org_study_id