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)

Coagulation Clinical Trial

— ECLIPSE 03  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00933738
• Other study ID #: BSTE-0120.a
• Status: Completed
• Phase: N/A
• First received: July 3, 2009
• Last updated: June 21, 2011
• Start date: December 2009
• Est. completion date: March 2011

Study information

• Verified date: June 2011
• Source: Biosite
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coagulation

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Biosite

Country where clinical trial is conducted

United States,