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

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

sites

Johns Hopkins University School of Medicine

733 North Broadway
Baltimore, Maryland 21205

(410) 955-3182