Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 259
- 试验地点
- 6
- 主要终点
- Number of bleeding occurrences
研究概览
简要总结
Life expectancy of haemophilia patients (specially severe) has dramatically increase in the last decades, which lead to the apparition of aging diseases such as cardiovascular disease, with the potential bleeding risk of antiplatelet therapies and anticoagulants.
The primary endpoint of the study is to evaluate this bleeding risk in haemophilia patients (all severity) with such treatment in comparison to non treated patients, according to the number of bleeding events in the last year reported by the haemophilia patients under study treatment (antiplatelet and anticoagulant) in comparison to haemophilia patients free of such treatment. The main hypothesis is that antiplatelet and anticoagulant therapy can be safely used in minor haemophilia patients but might lead to increase bleeding risk in other haemophilia patients.
Secondary endpoint consist in:
- Evaluate the impact of know cardio-vascular risk in haemophilia patients (Odd ratios=OR)
- Evaluate the number of sever bleeding event in patient under study treatments compared to the control group
- Evaluate the overall consumption of factor VIII or IX supply in patients under study treatments compared to control group
- Estimate the stenosis relapse risk in haemophilia patients with arterial STENT
- Estimate the embolic risk of haemophilia patients with atrial fibrillation
Population description:
Haemophilia patients (man, all severity)
Age above 50 years, followed during the last 5 years in one of the study centre
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age above 50 years
- •Hemophilia A or B carriers
- •Followed within the 5 last years in one of the research center
排除标准
- •Jurisdictional prevention procedures
- •Other medical condition that might interfere with the bleeding risk (Willebrand's disease, Other coagulation factor deficiencies, haematological malignancies, ...)
- •Other drugs that might interfere with the bleeding risk (Serotonin reuptake inhibitors)
- •Patient refusal
结局指标
主要结局
Number of bleeding occurrences
时间窗: last 12 months
次要结局
未报告次要终点
