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

NCT01036646 | Completed

• 1 other identifier: BSTE-0125
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 4

Brief Summary

This multi-center study is designed to evaluate the ability of intended lay users (patients on oral anticoagulation therapy, OAT, or their caregivers) to 1) operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, and 2) obtain accurate results for the quantitative determination of International Normalized Ratio (INR) when self-testing using fingerstick capillary blood. Patients will be trained by their healthcare provider using the instructions for use and product labeling provided. The accuracy of the patient INR results will be assessed by comparison to the INR results obtained by the site's trained healthcare professional using the same INRatio system (from a separate fingerstick collected from the same patient at the point-of-care), and with the INR results obtained on venous plasma obtained from the same patient and analyzed at a central laboratory with the Sysmex CA-560 System INR reference method.

Conditions

Oral Anticoagulation

Keywords

Patients on stable OAT therapy for at least 3 months.

Outcome Measures

Primary Outcomes (1)

• Operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity.

  8 weeks

Study Arms (2)

BSTE-0125-Original Protocol

BSTE-0125.a-Amended Protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from their primary care clinic.

You may qualify if:

• Adults (18 years of age or older);
• Ability to read and speak English;
• Subjects on stable oral anticoagulation therapy with warfarin (at least 3 months);
• Target INR interval between 2.0 and 4.5
• Willing and able to provide written informed consent and comply with study procedures;

You may not qualify if:

• Hematocrit less than 25 or greater than 55%
• Lupus or antiphospholipid syndrome (APS)
• Already participated in this study
• A current INRatio PT Monitoring System User / Patient Self Tester

Sponsors & Collaborators

• Abbott RDx Cardiometabolic: lead

Study Sites (4)

Loma Linda VA Hospital

Loma Linda, California, 92357, United States

Location

UC Davis Healthcare System

Sacramento, California, 95817, United States

Location

San Diego Cardiac Center

San Diego, California, 92123, United States

Location

Fox Valley Cardiology

Aurora, Illinois, 60504, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma specimens retained for reference method comparison.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: December 21, 2009
• Study Start: August 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: September 1, 2010
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

US (4)