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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21805
Enrollment
80
Registered
2021-04-20
Start date
2021-05-03
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antiphospholipid syndrome, thrombosis

Interventions

Patients will endure 1 finger stick procedure and 1 venepuncture,

Sponsors

Dutch Thrombosis Foundation
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to determine discrepancies between INR measurements with Coaguchek and Coagulometer in lupus anticoagulant positive APS patients.

Secondary

MeasureTime frame
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).

Contacts

Public ContactTessa Noordermeer

UMC Utrecht

t.noordermeer-2@umcutrecht.nl0629443806

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)