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Reliability of Point-of-care INR Measurements in Patients With Antiphospholipid-antibody Syndrome Treated With Warfarin

Antiphospholipid Syndrome Clinical Trial

Official title:
INR Determined by Plasma-based Methods Versus Newer Point-of-care Instruments in Patients With Antiphospholipid-antibody Syndrome Treated With Anticoagulants

Clinical Trial Summary

The antiphospholipid-antibody syndrome (APLA), which includes lupus anticoagulant, anticardiolipin, and anti-beta-2-glycoproteinI antibodies, is a thrombophilic disorder associated with arterial thrombosis, venous thrombosis or both. Patients diagnosed with APLA have a higher risk of recurrent thrombosis than do patients without known antibodies. Currently, warfarin is considered the anticoagulant of choice for prophylactic antithrombotic treatment for APLA patients after their first episode of thrombosis. In some patients with APLA who are treated with warfarin, the INR values determined on plasma are unreliable due to an influence of the APLA on the INR. In these individuals, alternative monitoring methods, such as factor II activity, chromogenic factor X activity or prothrombin-proconvertin time should be used to assess adequate anticoagulation. These tests are expensive and not widely available to some clinicians. Point-of-care (POC) instruments, on the other hand, are readily accessible to clinicians. Previous research has shown that INR values from 3 older point-of-care (POC) instruments are unreliable in 1/3 of APLA patients (CoaguChekTM, ProTimeTM, INRatioTM). However, there are now newer versions of these POC instruments available (CoaguChek XSTM, an investigational ProTime device, and a newer INRatioTM device) and it is unknown if these newer POC instruments are reliable in patients with APLA. The purpose of this study is to determine whether newer POC instruments are reliable in patients with APLA.

Clinical Trial Description

n/a

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00878137
Study type Observational
Source University of North Carolina, Chapel Hill
Contact
Status Completed
Phase N/A
Start date March 2009
Completion date May 2009
View Details
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