Laboratory and Clinical Data in Antiphospholipid Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood test.
- Who it may be relevant to
- Registry conditions: Antiphospholipid Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Constitution d'Une Collection d'Echantillons Biologiques Associee a Une Base de Donnees de Patients Possedant Des Anticorps Antiphospholipides
Overview
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 test Blood test
Blood test for the identification of biomarkers
Primary outcome measures
- Thrombosis [Time frame: Up to 10 years]
Secondary outcome measures (1)
- Bleeding [Time frame: Up to 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 2 centers
- CHRU de Lille — Lille
- CHRU de Nancy — Nancy
Identifiers
NCT: NCT04308564 · 2019-A02058-49