Laboratory and Clinical Data in Antiphospholipid Patients
- Conditions
- Antiphospholipid Syndrome
- Registration Number
- NCT04308564
- Lead Sponsor
- Central Hospital, Nancy, France
- Brief Summary
To constitute a registry of antiphospholipid antibodies positive-patients
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- age between 18 and 60 years;
- persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to screening
- no inform consent
- impossible follow up
- pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Thrombosis Up to 10 years Rate of thrombosis
- Secondary Outcome Measures
Name Time Method Bleeding Up to 10 years Rate of bleeding
Trial Locations
- Locations (2)
CHRU de Lille
🇫🇷Lille, France
CHRU de Nancy
🇫🇷Nancy, France