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Withdrawn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
About this trial
This is an observational trial for Blood Dyscrasia
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Comparison of INR measurements
Secondary Outcome Measures
Full Information
NCT ID
NCT02586818
First Posted
October 22, 2015
Last Updated
August 25, 2021
Sponsor
Accriva Diagnostics
Collaborators
University of Rochester
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Withdrawn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
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Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
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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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