Status:
COMPLETED
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)
Lead Sponsor:
Abbott RDx Cardiometabolic
Conditions:
Coagulation
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00933738
Start Date
December 1 2009
End Date
March 1 2011
Last Update
June 22 2011
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Loma Linda VA
Loma Linda, California, United States
2
University of Colorado-Denver
Aurora, Colorado, United States, 80045
3
Henry Ford Hospital
Detroit, Michigan, United States, 48202
4
Emergency Medicine Research Group
Lansing, Michigan, United States, 48910