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

NCT01037270 | Completed

• 1 other identifier: BSTE-0124
• Study Type: observational
• Target: 271
• Locations: 1 country
• Sites: 4

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.

Conditions

Pulmonary Embolism; Atrial Fibrillation; Deep Vein Thrombosis

Keywords

Patients with conditions (PE, Afib, DVT) requiring ongoing INR measurements.

Outcome Measures

Primary Outcomes (1)

• Analytical accuracy and precision of the INRatio Prothrombin Time (PT) Monitoring System.

  3-6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Approximately 210 subjects on OAT and 20 normal healthy subjects not on anticoagulation therapy will be enrolled.

You may qualify if:

• Adults (18 years of age or older);
• 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)
• Vulnerable populations deemed inappropriate for study by the site's principal investigator.
• Already participated in this study.

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 for reference testing.

MeSH Terms

Conditions

Pulmonary Embolism; Atrial Fibrillation; Venous Thrombosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thrombosis

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 22, 2009
• Study Start: August 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: February 11, 2013

Record last verified: 2013-02

Locations

US (4)