NCT00307580已完成4 期
Cathflo Activase (Alteplase) Pediatric Study (CAPS)
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 主要终点
- To evaluate the safety, as measured by the incidence of intracranial hemorrhage during the treatment with Cathflo Activase, in restoring function to dysfunctional CVADs in pediatric populations.
研究概览
简要总结
This was a Phase IV, open-label, single-arm, multicenter trial that was to be conducted at ~60 sites in the United States. Approximately 300 pediatric subjects with dysfunctional CVADs (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports) were to be treated with up to two serially instilled doses of Cathflo Activase.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects had to meet the following inclusion criteria to be eligible for study entry:
- •Less than 17 years of age
- •Clinically stable
- •Occlusion of CVAD (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports)
- •For subjects who weighed >= 10 kg, inability to withdraw 3 mL of blood from the CVAD
- •For subjects who weighed < 10 kg, inability to withdraw 1 mL of blood from the CVAD
- •Ability to infuse fluids at the volume necessary to instill Cathflo Activase into the CVAD
- •Written informed consent and assent (if appropriate) provided by parent or legal guardian and compliance with study assessments for the full duration of the study
排除标准
- •Ability to withdraw blood following subject repositioning
- •CVAD insertion < 48 hours prior to enrollment
- •Selected study catheter implanted specifically for hemodialysis
- •Evidence of mechanical, non-thrombotic occlusion of the CVAD (e.g., kink in the CVAD or suture constricting the catheter)
- •Previous enrollment in this study
- •Use of fibrinolytic agent (e.g., alteplase, reteplase, tenecteplase, urokinase, streptokinase) within 24 hours of enrollment
- •At high risk for bleeding events, embolic complications (i.e., recent pulmonary embolism, deep vein thrombosis, endarterectomy, clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constituted a significant hazard
- •Known hypersensitivity to alteplase or any component of the formulation
结局指标
主要结局
To evaluate the safety, as measured by the incidence of intracranial hemorrhage during the treatment with Cathflo Activase, in restoring function to dysfunctional CVADs in pediatric populations.
次要结局
- To estimate the rate of restoration of function to dysfunctional CVADs following administration of up to two instillations of Cathflo Activase.
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