Laboratory and Clinical Data in Antiphospholipid Patients (APSregistry)

Central Hospital, Nancy, France

Status: Enrolling

Conditions: Antiphospholipid Syndrome

Treatments: Diagnostic Test: Blood test

Study type: Observational

Funder types: Other

Identifiers

NCT04308564

2019-A02058-49

Details and patient eligibility

About

To constitute a registry of antiphospholipid antibodies positive-patients

Full description

An international web-based application, the REDCap (Research Electronic Data Capture), captures data on patient demographics, aPL-related clinical and laboratory characteristics, and medications. The inclusion criteria are: a) age between 18 and 60 years; and b) persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to screening; positivity is defined as anticardiolipin antibodies (aCL) IgG/M/A (> 40 GPL/MPL/APL, medium-to-high titer, and/or greater than the 99th percentile), anti-β2-glycoprotein-I (aβ2GPI) IgG/M/A (> 40 units, medium-to-high titer), positive lupus anticoagulant (LA) test based on International Society on Thrombosis and Hemostasis and other current guidelines. Patients are followed every 12 ± 3 months with clinical data and blood collection. Blood drawn is done at inclusion and every year.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age between 18 and 60 years;
• persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to screening

Exclusion criteria

• no inform consent
• impossible follow up
• pregnancy