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

Primary Purpose

Blood Dyscrasia

Status
Withdrawn
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
Accriva Diagnostics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Blood Dyscrasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Comparison of INR measurements

    Secondary Outcome Measures

    Full Information

    First Posted
    October 22, 2015
    Last Updated
    August 25, 2021
    Sponsor
    Accriva Diagnostics
    Collaborators
    University of Rochester
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02586818
    Brief Title
    Clinical Performance of Investigational InRhythm PT/INR System in a Professional Use Setting
    Official Title
    Clinical Performance of the Investigational InRhythm PT/INR System in a Professional Use Setting
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    August 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Product was discontinued.
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Accriva Diagnostics
    Collaborators
    University of Rochester

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Blood Dyscrasia

    7. Study Design

    Enrollment
    0 (Actual)
    Biospecimen Description
    Whole blood
    Primary Outcome Measure Information:
    Title
    Comparison of INR measurements
    Time Frame
    5 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Study Population Description
    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.
    Sampling Method
    Non-Probability Sample

    12. IPD Sharing Statement

    Learn more about this trial

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

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