AntiPhosphoLipid antibodies and point-of-care INR measurement with CoaguChek - VervOlg Studie

Recruiting

• Conditions: Antiphospholipid syndrome; 10064477; 10003816; 10014523

• Registration Number: NL-OMON56632
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 44

Inclusion Criteria

- Age 18 years and older
- Previously confirmed APS, diagnosed in accordance with the Sydney criteria
- High titers of anti-B2-glycoprotein-I IgG at screening (titer > 99th
percentile)
- Lupus anticoagulant positive at screening
- Receiving VKA during at least 3 months
- At least one thromboembolic event in the past
- Willing and be able to understand the study information and sign the informed
consent form

Exclusion Criteria

Patients with only obstetric complications of antiphospholipid syndrome without
thrombotic events

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the difference in INR values measured with the<br /><br>Coaguchek and Coagulometer.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameter includes the determination of antiphospholipid antibodies:<br /><br>IgG / IgM directed against cardiolipin, &beta;2-Glycoprotein I and prothrombin, and<br /><br>antiphospholipid antibodies that prolong the clotting time in vitro, known as<br /><br>lupus anticoagulant.</p><br>