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 (ECLIPSE-02)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biosite
ClinicalTrials.gov Identifier:
NCT01036646
First received: December 17, 2009
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

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.


Condition
Oral Anticoagulation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Biosite:

Primary Outcome Measures:
  • Operate the INRatio Prothrombin Time (PT) Monitoring System utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma specimens retained for reference method comparison.


Enrollment: 183
Study Start Date: August 2009
Study Completion Date: September 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
BSTE-0125-Original Protocol
BSTE-0125.a-Amended Protocol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients will be recruited from their primary care clinic.

Criteria

Inclusion Criteria:

  • 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;

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01036646

Locations
United States, California
Loma Linda VA Hospital
Loma Linda, California, United States, 92357
UC Davis Healthcare System
Sacramento, California, United States, 95817
San Diego Cardiac Center
San Diego, California, United States, 92123
United States, Illinois
Fox Valley Cardiology
Aurora, Illinois, United States, 60504
Sponsors and Collaborators
Biosite
  More Information

No publications provided

Responsible Party: Biosite
ClinicalTrials.gov Identifier: NCT01036646     History of Changes
Other Study ID Numbers: BSTE-0125
Study First Received: December 17, 2009
Last Updated: February 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Biosite:
Patients on stable OAT therapy for at least 3 months.

ClinicalTrials.gov processed this record on July 29, 2014