Constitution d'Une Collection d'Echantillons Biologiques Associee a Une Base de Donnees de Patients Possedant Des Anticorps Antiphospholipides
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Thrombosis
研究概览
简要总结
To constitute a registry of antiphospholipid antibodies positive-patients
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 60 years;
- •persistent (at least 12 weeks apart) aPL-positivity within 12 months prior to screening
排除标准
- •no inform consent
- •impossible follow up
- •pregnancy
结局指标
主要结局
Thrombosis
时间窗: Up to 10 years
Rate of thrombosis
次要结局
- Bleeding(Up to 10 years)
研究者
Pr Denis WAHL
Head of Vascular Medicine Division, Principal Investigator, Professor of Vascular Medicine
Central Hospital, Nancy, France
