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)

NCT00933738 | Completed

• 1 other identifier: BSTE-0120.a
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 12

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.

Conditions

Coagulation

Keywords

Patients needing OAT (Oral Anticoagulation Therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing heparin bridging onto OAT with warfarin.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott RDx Cardiometabolic: lead

Study Sites (12)

Loma Linda VA

Loma Linda, California, United States

Location

University of Colorado-Denver

Aurora, Colorado, 80045, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Emergency Medicine Research Group

Lansing, Michigan, 48910, United States

Location

Cardiac and Vascular Research Center of Northern Michigan

Petoskey, Michigan, United States

Location

International Heart Institute of Montana

Missoula, Montana, United States

Location

University of New Mexico

Albuquerque, New Mexico, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

John T Mather Memorial Hospital

Port Jefferson, New York, 11777, United States

Location

Northwest Heart Center

Tomball, Texas, United States

Location

Swedish Medical Center

Seattle, Washington, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples to be retained for reference testing and banking.

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 3, 2009
• First Posted: July 7, 2009
• Study Start: December 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: June 22, 2011

Record last verified: 2011-06

Locations

US (12)