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

Atrial Fibrillation Clinical Trial

— ECLIPSE-01  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037270
• Other study ID #: BSTE-0124
• Status: Completed
• Phase: N/A
• First received: December 17, 2009
• Last updated: February 8, 2013
• Start date: August 2009
• Est. completion date: June 2010

Study information

• Verified date: February 2013
• Source: Biosite
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: June 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Deep Vein Thrombosis
• Pulmonary Embolism
• Venous Thrombosis

Locations

Country	Name	City	State
United States	Fox Valley Cardiology	Aurora	Illinois
United States	Loma Linda VA Hospital	Loma Linda	California
United States	UC Davis Healthcare System	Sacramento	California
United States	San Diego Cardiac Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Biosite

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System.		3-6 months	No