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 study has been completed.
Sponsor:
Information provided by:
Biosite
ClinicalTrials.gov Identifier:
NCT00933738
First received: July 3, 2009
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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
Coagulation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Biosite:

Biospecimen Retention:   Samples Without DNA

Plasma samples to be retained for reference testing and banking.


Estimated Enrollment: 150
Study Start Date: December 2009
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
  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 undergoing heparin bridging onto OAT with warfarin.

Criteria

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
  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: NCT00933738

Locations
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
Biosite
  More Information

No publications provided

Responsible Party: Keith Gran / Sr. Clinical Trial Manager, Biosite, Incorporated a subsidiary of Inverness Medical Innovations
ClinicalTrials.gov Identifier: NCT00933738     History of Changes
Other Study ID Numbers: BSTE-0120.a
Study First Received: July 3, 2009
Last Updated: June 21, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014