Early Intrapleural TPA Instillation Versus Late
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Chest tube removal
研究概览
简要总结
Chest tubes are used for air or fluid removal from the pleural space. When a chest tube is placed, it can be hard for the fluid to drain.Tissue plasminogen activator (tPA) and DNase are given through the chest tube to help with draining the fluid. We are doing this research to see if early addition of tPA-DNase immediately after chest tube placement will help with better fluid draining.
详细描述
The purpose of this study is to determine the timing and efficacy of early administration and late administration of t-PA/DNase via thoracostomy (n=60). Patients will be identified from the Intensive Care Unit, Coronary Care Unit, and wards/stepdown units. Prior to chest tube placement, patients will be randomized to one of the two treatment arms (early use of t-PA-DNase verus late use of t-PA-DNase). Route of administration will be via their thoracostomy tube over a period of three days twice daily.
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, age 18 years or older
- •Patients with an indication for a thoracostomy tube placement for a pleural effusion
排除标准
- •Patients that require a thoracostomy tube for a pneumothorax
- •Pregnant women
- •Sensitivity to t-PA, or DNase
- •Patients taking carbamazepine or nitroglycerin
- •Lung volume reduction surgery on side of pleural effusion
结局指标
主要结局
Chest tube removal
时间窗: 7 days
Time to chest tube removal
次要结局
- Fluid drainage(3 days)
- Need for other interventions(4 days)
- Discharge(3 weeks)