Intrapleural Thrombolytic Treatment With Urokinase for Retained Hemothorax: A Prospective Double-blinded Randomized Multicenter Study
试验速览
- 阶段
- 3 期
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- non-surgical rate
研究概览
简要总结
Intrapleural thrombolytic treatment with urokinase for retained hemothorax is effective and safe. However, previous study was limited in prospective observation study without control group.
详细描述
We will recruit 32 patients in this study. The patients with retained hemothorax will be randomly divided into the urokinase group and the placebo group. In the urokinase group, urokinase 100,000 IU in 100 mL NaCl will be injected into the intrapleural space. We will record the daily drainage amount and evaluate the therapeutic effect by the chest X-ray. The therapeutic effect, safety, hospital stay, and medical cost between the two groups will be compared. This study will be done in four medical centers in northern Taiwan.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Retained hemothorax: it is defined as chest X-ray revealing obvious blood clot in pleural cavity after tube thoracostomy drainage for 3 days. The chest tubes are in good location and have no obstruction. The physician thinks the blood clot is difficult to drain.
- •Age: full 18 year-old
排除标准
- •Active bleeding
- •Coagulopathy, e.g. congenital or acquired coagulation abnormality, platelet count less than 100,000 /μL, international normalized ratio (INR) more than 1.5, or partial thromboplastin time, PTT, more than 50 seconds after treatment.
- •Cerebrovascular accident within 30 days
- •History of intracranial tumor or vascular abnormality
- •Have received thoracic surgery
- •Have received pleurodesis
- •Wish to receive thoracoscopic surgery for hematoma evacuation directly
- •Allergy to urokinase
- •People who are less than 18 years of age, prisoners, aborigines.
研究组 & 干预措施
Urokinase
arm of interest
干预措施: urokinase (Drug)
Control
Normal saline as a placebo for control arm
干预措施: placebo (Drug)
结局指标
主要结局
non-surgical rate
时间窗: about 5 days
Complete response and partial response
次要结局
未报告次要终点