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

Blood Dyscrasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02586818
• Other study ID #: INR_CSP_015_0002_RA
• Status: Withdrawn

Study information

• Verified date: August 2021
• Source: Accriva Diagnostics
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Dyscrasia
• Hematologic Diseases

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Accriva Diagnostics	University of Rochester

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of INR measurements		5 weeks