NCT01246453已完成4 期
A Prospective, Randomized, Double Blind, Controlled Trial to Evaluate Efficacy and Security of Intrapleurally Alteplase vs Urokinase for the Treatment of Complicated Parapneumonic Effusion and Pleural Empyema
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- To evaluate the efficacy and safety of intrapleural alteplase vs urokinase in patients with complex complicated parapneumonic pleural effusion and empyema during one year of follow-up.
研究概览
简要总结
- Objectives:
- Main objective: To evaluate the efficacy and safety of intrapleural alteplase vs urokinase in patients with complex complicated parapneumonic pleural effusion and empyema.
- To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase
- To evaluate the safety of alteplase in the treatment of complex complicated parapneumonic pleural effusion and empyema
- Design: Multicentric, randomized, parallel, controlled and double blind
- Main variable: Percentage of curation
- Study population and number of patients: 204 patients with complex complicated parapneumonic pleural effusions and empyema
- Duration of the treatment: Three days (main variable), and optional three days (secondary variable)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Empyema and Complex Complicated Parapneumonic Pleural Effusion
排除标准
- •Pregnancy or breastfeeding
- •Critically illness
- •Systemic anticoagulant treatment
- •Coagulation Disorder
- •Bronchopleural fistula
- •Active bleeding
- •Recent punction of noncompressive artery
- •Stroke in the last 6 months
- •Major intervention o major traumatism in the last 6 weeks
- •Hypersensibility to urokinase or alteplase
- •Severe Liver or kidney failure
- •Inclusion in another interventional study in the last month
研究组 & 干预措施
urokinase
Active Comparator
干预措施: Intrapleurally Alteplase vs Intrapleurally Urokinase (Drug)
Alteplase
Active Comparator
干预措施: Intrapleurally Alteplase vs Intrapleurally Urokinase (Drug)
结局指标
主要结局
To evaluate the efficacy and safety of intrapleural alteplase vs urokinase in patients with complex complicated parapneumonic pleural effusion and empyema during one year of follow-up.
时间窗: Evaluation at three and 6 days of treatment
It will be also an evaluation at one month, six months and one year
次要结局
- To evaluate the pleural and plasmatic levels of the fibrinolytic system markers after the treatment with alteplase vs urokinase(Evaluation at three and 6 days of treatment)
研究者
研究点 (2)
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