Antiphospholipid Syndrome
Conditions
Keywords
antiphospholipid antibodies
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.
Interventions
DIAGNOSTIC_TESTBlood test
Blood test for the identification of biomarkers
Sponsors
Central Hospital, Nancy, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Thrombosis | Up to 10 years | Rate of thrombosis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding | Up to 10 years | Rate of bleeding |
Countries
France
Outcome results
None listed