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

NCT02586818 | Withdrawn

• 1 other identifier: INR_CSP_015_0002_RA
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Comparison of INR measurements

  5 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• The subject must require oral VKA anticoagulant therapy.
• The patient must have been anticoagulated for at least three months prior to enrollment.
• \- Subjects receiving any form of anticoagulation drugs such as Aspirin or Clopidogrel.

Sponsors & Collaborators

• Accriva Diagnostics: lead
• University of Rochester: collaborator

Biospecimen

Whole blood

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 26, 2015
• Primary Completion: July 1, 2017
• Last Updated: August 30, 2021

Record last verified: 2021-08