Evaluation of the Accuracy of the INRatio Prothrombin Time (PT) Monitoring System With a New Test Strip for the Oral Anticoagulation Therapy Patient in the Presence of Heparin and Low Molecular Weight Heparin (e.g., Enoxaparin or Dalteparin) (ECLIPSE 03)

This is a multi-center study designed to evaluate the heparin insensitivity of the INRatio Prothrombin Time (PT) Monitoring System, utilizing an INRatio test strip additionally modified for low sample volume. The INRatio test strip is used for the quantitative determination of PT and International Normalized Ratio (INR) results in fingerstick blood from subjects on oral anticoagulation therapy (OAT) with warfarin. This study is designed to evaluate the accuracy of the modified INRatio test strip during heparin-warfarin bridge therapy with unfractionated heparin (UH) or low molecular weight heparin (LMWH), such as enoxaparin or dalteparin. These INR results will be compared to the INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the heparin-insensitive reference method: the Sysmex CA-560 System. The levels of UH or LMWH in the plasma samples will be assessed using activated partial thromboplastin time (aPTT) and anti-factor-Xa assays respectively.

Study Overview

• Status: Completed
• Conditions: Coagulation

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States
      • Loma Linda VA
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado-Denver
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Lansing, Michigan, United States, 48910
      • Emergency Medicine Research Group
    • Petoskey, Michigan, United States
      • Cardiac and Vascular Research Center of Northern Michigan
  • Montana
    • Missoula, Montana, United States
      • International Heart Institute of Montana
  • New Mexico
    • Albuquerque, New Mexico, United States
      • University of New Mexico
  • New York
    • Brooklyn, New York, United States, 11215
      • New York Methodist Hospital
    • Port Jefferson, New York, United States, 11777
      • John T Mather Memorial Hospital
  • Texas
    • Tomball, Texas, United States
      • Northwest Heart Center
  • Washington
    • Seattle, Washington, United States
      • Swedish Medical Center
    • Wenatchee, Washington, United States
      • Wenatchee Valley Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing heparin bridging onto OAT with warfarin.

Description

Inclusion Criteria:

• Adults (18 years of age or older).
• Willing and able to provide written informed consent and comply with study procedures.
• Receiving warfarin/heparin bridge therapy.
• Therapy with both warfarin and one of the heparins listed below must have been initiated for at least 12 hours before the first study specimens are obtained.
• UH (last known aPTT prior to enrollment (if available†) must confirm heparin has been administered)
• Dalteparin (last known anti-factor Xa prior to enrollment (if available†) must confirm heparin has been administered)
• Enoxaparin (last known anti-factor Xa prior to enrollment (if available†) must confirm heparin has been administered) † If a pre-study aPTT or anti-factor Xa is not available, subsequent testing of the study phlebotomy or a phlebotomy as a part of routine medical care taken before or during the time of the study phlebotomy must confirm the presence of heparin (unfractionated or low molecular weight) in order for that data point to be included in the analysis.

Exclusion Criteria

• Known or suspected hematocrit less than 25 or greater than 55%;
• Auto-immune disorders known to interfere with INR measurements, such as lupus or anti-phospholipid syndrome (APS)
• Already participated in this specific study

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Biosite

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: July 3, 2009
• First Submitted That Met QC Criteria: July 6, 2009
• First Posted (ESTIMATE): July 7, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): June 22, 2011
• Last Update Submitted That Met QC Criteria: June 21, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Patients needing OAT (Oral Anticoagulation Therapy)
• Other Study ID Numbers: BSTE-0120.a