The Role of Inhalations of Tranexamic Acid in Patients With Hemoptysis
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- bleeding stops
研究概览
简要总结
Hemoptysis is defined as the expectoration of blood from respiratory tract, a spectrum that varies from blood-streaking of sputum to coughing up large amounts of pure blood.
Massive hemoptysis variably defined as the expectoration of 100-600 ml over 24-h period.
The most common site of bleeding is the tracheobronchial tree, which can be affected by inflammation (acute or chronic bronchitis, bronchiectasis) or by neoplasm ( bronchogenic carcinoma, endobronchial metastatic carcinoma, bronchial carcinoid tumor). The bronchial arteries, which originate either from aorta or from intercostal arteries, and are part of the high-pressure systemic circulation, are the source of bleeding in bronchitis or bronchiectasis or endo bronchial tumors.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18
- •Hemodynamicaly stable
- •Hemoptysis of varying etiologies
- •Coumadin treatment will be switched to clexane or heparine
排除标准
- •Age < 18
- •Hemodinamicaly unstable
- •Massive hemoptysis ( > 200 ml / day)
- •Renal failure: creatinine > 3, renal replacement treatment
- •Hepatic failure: bilirubin > 2 mg/dl, AST > 3 of upper normal limit level
- •Coagulation disorders, INR>
- •Hypesensitivity to tranexamic acid
- •Pregnant woman
研究组 & 干预措施
tranexamic acid-500 mg/5 ml 3-4 times a day
tranexamic acid arm: inhalations of tranexamic acid 500 mg/5 ml 3-4 times a day
干预措施: tranexamic acid (Drug)
tranexamic
placebo arm
干预措施: tranexamic acid (Drug)
结局指标
主要结局
bleeding stops
时间窗: 1 year
次要结局
未报告次要终点