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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Blood Dyscrasia

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population to be studied consists of subjects who require oral anticoagulant therapy with VKA in accordance with the approved label indications for VKA administration. Normal healthy individuals will also be enrolled to collect data to support the low end of the lnRhythm system detection range.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of INR measurements	5 weeks

Collaborators and Investigators

• Sponsor: Accriva Diagnostics
• Collaborators: University of Rochester

Study record dates

Study Major Dates

• Primary Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: October 22, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 26, 2015

Study Record Updates

• Last Update Posted (Actual): August 30, 2021
• Last Update Submitted That Met QC Criteria: August 25, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases
• Other Study ID Numbers: INR_CSP_015_0002_RA