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临床试验/NCT04308564
NCT04308564招募中不适用

Constitution d'Une Collection d'Echantillons Biologiques Associee a Une Base de Donnees de Patients Possedant Des Anticorps Antiphospholipides

Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年4月12日最近更新:
适应症

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

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

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pr Denis WAHL

Head of Vascular Medicine Division, Principal Investigator, Professor of Vascular Medicine

Central Hospital, Nancy, France

研究点 (2)

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