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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00933738
Recruitment Status : Completed
First Posted : July 7, 2009
Last Update Posted : June 22, 2011
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Brief Summary:
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.

Condition or disease

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : December 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
U.S. FDA Resources

Biospecimen Retention:   Samples Without DNA
Plasma samples to be retained for reference testing and banking.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing heparin bridging onto OAT with warfarin.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00933738

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

Responsible Party: Keith Gran / Sr. Clinical Trial Manager, Biosite, Incorporated a subsidiary of Inverness Medical Innovations Identifier: NCT00933738     History of Changes
Other Study ID Numbers: BSTE-0120.a
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

Keywords provided by Biosite:
Patients needing OAT (Oral Anticoagulation Therapy)

Additional relevant MeSH terms:
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action