Evaluation of the Accuracy and Precision of the INRatio® Prothrombin Time (PT) Monitoring System With New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

271 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-06-30

Brief Summary

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This is a multi-center study designed to evaluate the accuracy and precision of the INRatio® Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, when used by trained medical professionals for the quantitative determination of PT and International Normalized Ratio (INR) in fingerstick and venous whole blood from subjects on oral anticoagulation therapy (OAT). These results will be compared to those PT/INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the Sysmex CA-560 System.

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Detailed Description

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Conditions

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Pulmonary Embolism Atrial Fibrillation Deep Vein Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adults (18 years of age or older);
* Willing and able to provide written informed consent and comply with study procedures;
* Subjects on oral anticoagulation therapy. This inclusion criterion is waived for the 20 normal healthy volunteers who must NOT be on warfarin or any other anticoagulant drug.

Exclusion Criteria

* Hematocrit less than 25 or greater than 55%;
* Lupus or antiphospholipid syndrome (APS)
* Vulnerable populations deemed inappropriate for study by the site's principal investigator.
* Already participated in this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes