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

Accriva Diagnostics

Status: Withdrawn

Conditions: Blood Dyscrasia

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02586818

INR_CSP_015_0002_RA

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria - All

• 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.

Exclusion Criteria - All

• 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.

Additional Inclusion Criteria - Therapeutic Group

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

Additional Exclusion Criteria - Normal Group

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