Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.
研究概览
简要总结
The purpose of this study is to assess the benefit to patients with empyema or complicated parapneumonic effusion (CPE) using a daily versus twice daily Alteplase regimen of two different dose strategies compared with saline placebo.
详细描述
This is a randomized, double-blind, placebo-controlled pilot study. Patients with empyema and complicated parapneumonic effusion who are felt to require fibrinolytic therapy will be considered for study enrollment. Enrolled patients will be randomized to one of five potential treatment arms (saline placebo, 4 mg once daily, 4 mg twice daily, 10 mg once daily, or 10 mg twice daily) in a double-blinded manner.
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
- Double
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
- •Ability to provide written informed consent
- •Age greater or equal to 18 yrs
- •Presence of empyema or CPE
排除标准
- •Active internal bleeding
- •Pregnancy
- •Prior enrollment in this study
- •Platelet count less than 100,000/mm3
- •Use of warfarin sodium if INR is greater than 1.7
- •Use of heparin unless the PTT is less than 1.5 times baseline normal
- •Known neurological disorders
- •Current or pre-existing bleeding dyscrasia
- •Known allergy to Alteplase
结局指标
主要结局
Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy.
次要结局
- Mortality
- Hospital length of stay
- Daily chest tube drainage
- Radiographic improvement