Interest of Sublingual Videomicroscopy for the Prediction of Bleeding in Von Willebrand Disease and Other Constitutional Haemorrhagic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- area under the ROC curve from Sublingual capillary density to inclusion for the event "existence of at least a clinically significant haemorrhage"
研究概览
简要总结
In Willebrand disease, there is currently no test available to identify non-invasively patients with a high risk of bleeding from angiodysplasias The study propose to use a sublingual capillary bed analysis by video-microscopy, a sensitive, reproducible and non-invasive technique, to assess whether sublingual capillary density is predictive of hemorrhagic risk for patients with von Willebrand disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adult patient with a significant form of von Willebrand disease (according to the inclusion criteria of the Willebrand Disease French Reference Center), a Glanzmann Thrombasthenia, a moderate to severe Haemophilia A or a woman carrying the hemophilia gene
- •Social insured patient
排除标准
- •Minor patient
- •Refusal of consent
- •Person benefiting from a system of legal protection
- •Pregnant patient
研究组 & 干预措施
Patients with haemorrhagic disease
Patients with von Willebrand disease or Patients with Glanzmann Thrombasthenia
干预措施: Sublingual videomicroscopy (Device)
Patients with haemorrhagic disease
Patients with von Willebrand disease or Patients with Glanzmann Thrombasthenia
干预措施: blood sample (Biological)
Control group
Patients with moderate or severe hemophilia A or women carrying the hemophilia gene
干预措施: Sublingual videomicroscopy (Device)
结局指标
主要结局
area under the ROC curve from Sublingual capillary density to inclusion for the event "existence of at least a clinically significant haemorrhage"
时间窗: at 3 years
次要结局
- delta of increase in plasma levels of all proangiogenic markers(At inclusion and end of study (at 3 years))
- ISTH-BAT haemorrhagic score (International Society on Thrombosis and Hemostasis - Bleeding Assessment Tool)(At baseline, at 3 years)
- plasma levels of VEGF(at inclusion and end-of-study visits(at 3 years))
- delta of Sublingual capillary density increase(between inclusion and end of study (at 3 years))
- delta of increase of ISTH-BAT haemorrhagic score(between inclusion and end of study (at 3 years))
- plasma levels of proangiogenic markers(at inclusion and end-of-study visits(at 3 years))
- plasma levels of galectine(at inclusion and end-of-study visits(at 3 years))
- Sublingual capillary density(At baseline)
- qualitative abnormalities of sublingual capillaries (capillary haemorrhage, capillary dystrophy)(At baseline and at 3 years)