NCT00798278已完成3 期
Exploratory Multicentre Clinical Trial to Compare the Efficacy of Urokinase Versus Video-assisted Thoracoscopic for Treatment of Complicated Parapneumonic Empyema in Childhood
Spanish Society of Pediatric Surgery6 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 6
- 主要终点
- duration of the hospital stay after the treatment
研究概览
简要总结
A great controversy exists about which is the best method to perform the evacuation of the collection. The purpose of this study is to evaluate which is the best initial treatment to drain complicated parapneumonic empyema (stages II and III) in children: the present study raises a hypothesis of equivalence between both arms of treatment (chest drainage plus intrapleural urokinase or videothoracoscopic debridement).
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
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients less than 15 years of age with pneumonia and persistent fever, and complicated parapneumonic empyema (septation or loculation seen on ultrasound or Rx thorax)stages II and III requiring an intervention to drain
排除标准
- •Existing contraindications or other previous conditions, hypertension, pneumothorax
研究组 & 干预措施
Urokinase
Experimental
urokinase infusion for 3 days
干预措施: Urokinase (Drug)
Thoracoscopic
Active Comparator
Video-Assisted Thoracoscopic
干预措施: Video-Assisted Thoracoscopic (Procedure)
结局指标
主要结局
duration of the hospital stay after the treatment
时间窗: 3 months
次要结局
- complications of the treatment and complications of the disease(3 months)
- total duration of the hospital stay(3 months)
- number of days carrying the chest drain(3 months)
- duration of the fever once the empyema has been drained(3 months)
研究者
研究点 (6)
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