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The influence of antiphospholipid antibodies on INR values measured with the CoaguChek XS

Conditions
Antiphospholipid syndrome, thrombosis
Registration Number
NL-OMON21805
Lead Sponsor
Dutch Thrombosis Foundation
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
80
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:
-Age 18 years and older
-Previously confirmed APS, diagnosed in accordance with the Sydney criteria22
-Receiving VKA during at least 3 months
-Willing and be able to understand the study information and sign the informed consent form

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:
-None

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary objective of this study is to determine discrepancies between INR measurements with Coaguchek and Coagulometer in lupus anticoagulant positive APS patients.
Secondary Outcome Measures
NameTimeMethod
The secondary objective of this study is to investigate which antiphospholipid antibodies correlate with the found INR discrepancies. Furthermore, we will look into the differences within two different groups of APS patients: triple positive APS patients (tested positive for at least lupus anticoagulant, anti-cardiolipin antibodies and anti-ß2-glycoprotein I antibodies) and non-triple positive patients (tested positive for at least lupus anticoagulant).
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