跳至主要内容
临床试验/NCT03157154
NCT03157154已完成不适用

Bleeding Risk Evaluation in Haemophilia Patients Under Antiplatelet Therapies

Nantes University Hospital6 个研究点 分布在 1 个国家目标入组 259 人开始时间: 2017年6月27日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

Loading locations...

相似试验