Prospective Study of Antiplatelet and Anticoagulation Therapy in Hereditary Haemorrhagic Telangiectasia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 28
- 主要终点
- Number of transfusions and/or intravenous iron
研究概览
简要总结
The goal of this clinical trial is to evaluate in real life, in patients with Hereditary Hemorrhagic Telangiectasia (HHT), the tolerance of the strategy of use of anticoagulant and/or antiplatelet, by comparing a new exposure period (first trimester of treatment) to a period of reference non-exposure (last trimester before start of treatment).
详细描述
Currently there are no recommendations on the use of anticoagulant and/or antiplatelet treatment in patients with Rendu-Osler Disease.
The main question this study aims to answer is:
• to better determine which anticoagulant and/or antiplatelet therapy are best tolerated or if they are equivalent in Rendu-Osler disease because this type of treatment is often used in urgent and/or vital situations.
Participants will have a 2-year follow-up with biological monitoring of ferritin and hemoglobin level and ESS (Epistaxis Severity Score) and QoL-HHT (Quality of Life Hereditary Hemorrhagic Telangiectasia) questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patient with Rendu-Osler disease with an indication of antiplatelet and/or anticoagulant introduced for less than 3 months (inclusion period within 3 months of exposure)
- •Age > 18 years old
- •Patient able to understand and agree to participate in the study
- •Affiliation to a social security system
排除标准
- •Patient with an indication of antiplatelet and/or anticoagulant but for whom treatment has not been introduced or introduced for more than 3 months
- •Refusal to participate
- •Pregnant woman or who are breast feeding
- •Patients under maintenance of justice, wardship or legal guardianship
研究组 & 干预措施
Cohort study
a single arm, the anticoagulant and/or antiplatelet treatment is not conditioned by the study
干预措施: monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease (Other)
结局指标
主要结局
Number of transfusions and/or intravenous iron
时间窗: 3 months after exposure to anticoagulants and/or antiplatelet
Number of transfusions and/or intravenous iron before (3 months) and within 3 months after exposure to anticoagulants and/or antiplatelet in patients with Rendu-Osler disease.
次要结局
- Biological parameters(3 months after exposure to anticoagulants and/or antiplatelet)
- Evaluation of Quality of life(week 6, 12, 52 and 104 after patient inclusion)
- Bleeding(3 months after exposure to anticoagulants and/or antiplatelet)
- Anticoagulant and/or antiplatelet treatment(week 104 after patient inclusion)
- Thrombotic accident(week 104 after patient inclusion)
- Epistaxis(week 12, 52 and 104 after patient inclusion)