Status:
COMPLETED
Reliability of Point-of-care INR Measurements in Patients With Antiphospholipid-antibody Syndrome Treated With Warfarin
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
International Technidyne Corporation
Conditions:
Antiphospholipid Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
The antiphospholipid-antibody syndrome (APLA), which includes lupus anticoagulant, anticardiolipin, and anti-beta-2-glycoproteinI antibodies, is a thrombophilic disorder associated with arterial throm...
Eligibility Criteria
Inclusion
- APLA
- Prolongation of a phospholipid-dependent screening assay, 2) lack of correction of a prolonged screening assay after a 1:1 mix with pooled normal plasma, and 3) correction of a prolonged screening assay by the addition of excess phospholipid. Two positive lupus anticoagulant confirmations at least 3 months apart will be required.
- Diagnosis of anticardiolipin antibodies defined as elevated levels of ACA-IgG (\>30) and/or ACA-IgM (\>15) on two separate occasions at least 3 months apart.
- Stable warfarin therapy, defined as the maintenance of a warfarin dose for a minimal of 2 weeks regardless of INR.
- APLA
Exclusion
- Patients whose warfarin dose has changed within the past 2 weeks.
- Control Inclusion Criteria:
- No evidence of either a positive LA or ACA diagnosis by confirmation of negative laboratory values and/or documentation of no clinical signs and symptoms concurrent with these conditions.
- Stable warfarin therapy, defined as the maintenance of a warfarin dose for a minimal of 2 weeks regardless of INR.
- Control
Key Trial Info
Start Date :
March 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00878137
Start Date
March 1 2009
End Date
May 1 2009
Last Update
October 15 2012
Active Locations (1)
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1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514