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

Completed

• Conditions: Pulmonary Embolism; Atrial Fibrillation; Deep Vein Thrombosis

• Registration Number: NCT01037270
• Lead Sponsor: Abbott RDx Cardiometabolic

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-19
• Study First Posted: 2009-12-22
• Primary Completion: 2010-04
• Study Completion: 2010-06
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-08
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System.	3-6 months

Trial Locations

Locations (4)

Loma Linda VA Hospital; 🇺🇸 Loma Linda, California, United States

Fox Valley Cardiology; 🇺🇸 Aurora, Illinois, United States

San Diego Cardiac Center; 🇺🇸 San Diego, California, United States

UC Davis Healthcare System; 🇺🇸 Sacramento, California, United States