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



Status:Not yet recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:October 2015
End Date:January 2016
Contact:Loralie Yzerman, RN BScN CCRN
Email:lyzerman@accriva.com
Phone:760-443-9243

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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/Innovin) calibrated to the WHO
rTF09 reference standard.

The study will be performed at a minimum of three (3) different clinical sites where
patients' VKA therapy is managed and routine PT/INR monitoring is performed.

Inclusion Criteria:

- 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.

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.

Exclusion Criteria:

- 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 Exclusion Criteria - Normal Group

- Subjects receiving any form of anticoagulation drugs such as Aspirin or Clopidogrel.
We found this trial at
3
sites
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Majed A Refaai, MD
Phone: 585-276-3927
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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733 North Broadway
Baltimore, Maryland 21205
(410) 955-3182
Principal Investigator: William Clarke, PhD DABCC
Phone: 410-502-8642
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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Loma Linda, California 92357
Principal Investigator: Ronald Fernando, MD
Phone: 909-583-6361
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Loma Linda, CA
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