NCT01037270

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 271 (actual)
• Sponsor: Abbott RDx Cardiometabolic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pulmonary Embolism
• Atrial Fibrillation
• Deep Vein Thrombosis

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-04-01
• Completion: 2010-06-01
• First posted: 2009-12-22
• Last updated: 2013-02-11

Locations

4 sites across 1 country: United States