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

Sponsor
Accriva Diagnostics (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT02586818
Collaborator
University of Rochester (Other)
0
Enrollment

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Official Title:
    Clinical Performance of the Investigational InRhythm PT/INR System in a Professional Use Setting
    Anticipated Primary Completion Date :
    Jul 1, 2017

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of INR measurements [5 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Accriva Diagnostics
    • University of Rochester

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Accriva Diagnostics
    ClinicalTrials.gov Identifier:
    NCT02586818
    Other Study ID Numbers:
    • INR_CSP_015_0002_RA
    First Posted:
    Oct 26, 2015
    Last Update Posted:
    Aug 30, 2021
    Last Verified:
    Aug 1, 2021
    Additional relevant MeSH terms:
    Hematologic Diseases

    Study Results

    No Results Posted as of Aug 30, 2021