Drainage or Pericardiocentesis Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 122
- 试验地点
- 7
- 主要终点
- Recurrent pericardial effusion
研究概览
简要总结
The DROP study is a prospective, multi center, randomized, open-label trial to test the efficacy and safety of extended catheter pericardial drainage in patients with non-malignant pericardial effusions.
详细描述
The trial will compared the efficacy and safety of pericardiocentesis alone compared with extended pericardial catheter drainage for the prevention of recurrent effusions in patients with non-malignant pericardial effusions requiring intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •pericardial effusion requiring pericardiocentesis
- •non-malignant etiology
排除标准
- •known neoplastic etiology
- •known bacterial etiology
研究组 & 干预措施
Pericardiocentesis
Pericardial fluid drained by simple echo-guided pericardiocentesis
Extended pericardial drainage
Extended pericardial drainage will include pericardiocentesis followed by an intermittent pericardial catheter drainage. Pericardial drainage will be kept till daily fluid return<30ml
干预措施: Extended pericardial drainage by catheter (Procedure)
结局指标
主要结局
Recurrent pericardial effusion
时间窗: 12 months
Need for cardiac surgery
时间窗: 12 months
Need for repeated pericardiocentesis
时间窗: 12 months
次要结局
- Overall mortality(12 months)
- Hospital stay(12 months)
- Disease-related hospitalization(12 months)
研究者
Massimo Imazio
Cardiologist
Maria Vittoria Hospital