A Multicenter, Open-label, Randomised, Clinical Trial to Compare the Efficacy and Safety of Actilyse 2 mg/ 2 ml Versus Saline Solution in Restoring Function of an Occluded Central Venous Access Device
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 5
- 主要终点
- Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First Dose of Study Medication
研究概览
简要总结
This is a multicentre, open-label, randomised, phase III study designed to evaluate the efficacy and safety of Actilyse 2 mg/2 ml in the restoration of function of CVAD
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 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
Actilyse 2 mg/2 ml
First dose of Actilyse 2mg/2ml will be given at time 0. Second dose will be given at 120 if CVAD function has not been restored.
干预措施: Actilyse (Drug)
Saline solution (NaCl 0.9%)
Saline solution will be given at time 0. First dose of Actilyse 2mg/2ml will be given to patients if CVAD function has not been restored.
干预措施: Actilyse (Drug)
Saline solution (NaCl 0.9%)
Saline solution will be given at time 0. First dose of Actilyse 2mg/2ml will be given to patients if CVAD function has not been restored.
干预措施: Saline solution (Drug)
结局指标
主要结局
Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First Dose of Study Medication
时间窗: 120 minutes after first drug administration
Proportion (percentage) of patients with restored central venous access device (CVAD) function at 120 min after administration of the first dose of study medication (i.e. Actilyse® or saline solution).
次要结局
- Restored CVAD Function 30 Minutes After Administration of Study Medication at Time 0(30 minutes after first drug administration)
- Percentage of Participants Who Achieved Restored CVAD Function After 1 Dose and 2 Doses, in Patients From the Actilyse Treatment Group.(0 minutes and 240 minutes)
- Restored CVAD Function 30 Minutes After Administration of the Second Dose of Study Medication Actilyse(150 minutes after first drug administration)
- Restored CVAD Function 120 Minutes After Administration of the Second Dose of Study Medication Actilyse(240 minutes after first drug administration)