Safety of Dabigatran Etexilate (DE) for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Paediatric Patients From Birth to Less Than 2 Years of Age: a Prospective European Non-interventional Cohort Study Based on New Data Collection
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- Incidence of any bleeding events defined as Major Bleeding Events (MBE) or Non-Major Bleeding Events (Non-MBE)
研究概览
简要总结
The study is designed to collect and evaluate Dabigatran Etexilate (DE) safety in the context of routine anticoagulation care provided in the European Union (EU)/European Economic Area (EEA) for children under 2 years of age.
The non-interventional study will be conducted in paediatric hospitals or paediatric departments of EEA member states where Venous thromboembolism (VTE) patients of the evaluated age group are treated.
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
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Pediatric patients eligible for Dabigatran Etexilate (DE) VTE treatment and secondary VTE prevention
干预措施: Dabigatran Etexilate (DE) (Drug)
结局指标
主要结局
Incidence of any bleeding events defined as Major Bleeding Events (MBE) or Non-Major Bleeding Events (Non-MBE)
时间窗: up to 6 months
Major bleeding defined as: * Fatal Bleeding, * Clinically overt bleeding associated with a decrease in haemoglobin of at least 2 g/dL (20 g/L) in a 24-hour period, * Bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the central nervous system, * Bleeding that requires surgical intervention in an operating suite. Non-Major bleeding defined as: - Any overt or macroscopic evidence of bleeding that does not fulfil the criteria for major bleeding. (Criteria for differentiation of Major Bleeding Events (MBEs) and Non-MBEs by the Perinatal and Paediatric Haemostasis Subcommittee of the Scientific and Standardization Committee (SSC) of the International Society on Thrombosis and Haemostasis (ISTH).)
次要结局
- Incidence of Adverse Events (AEs)(up to 6 months)
- Incidence of Serious Adverse Events (SAEs)(up to 6 months)