NCT01862458撤回3 期
Prospective Randomized Trial: Fibrinolysis With tPA (Tissue Plasminogen Activator) Versus tPA and DNAse in Children With Empyema
Children's Mercy Hospital Kansas City2 个研究点 分布在 1 个国家开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Length of stay
研究概览
简要总结
The objective of this study is to scientifically evaluate a new substrate for fibrinolysis compared to our standard tPA.
The hypothesis, driven by a recent prospective trial, is that tPA may benefit from the addition of DNAse.
The primary outcome variable between the two techniques will be length of hospitalization after initiation of treatment.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patients less than 18 years of age requiring an intervention for empyema by one of the following:
- •Septation or loculation seen on ultrasound or computed tomography or
- •Greater than 10,000 white blood cells identified on pleural tap
排除标准
- •Immunodeficiency process
- •Secondary diagnosis or condition that will keep them in the hospital beyond the empyema
- •Existing contraindications to chest tube
- •Documented allergy to one of the study medications
结局指标
主要结局
Length of stay
时间窗: 3 weeks
次要结局
未报告次要终点
研究者
Shawn St. Peter
Assoc Prof
Children's Mercy Hospital Kansas City
研究点 (2)
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