Prophylactic Tranexamic Acid Versus Adrenaline for Bleeding Prevention During Flexible Bronchoscopy: a Double Blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,013
- 试验地点
- 1
- 主要终点
- Number (N) of bleeding episodes / bleeding rate (%) in each group
研究概览
简要总结
Endobronchial bleeding is a common complication of bronchoscopy. Major bleeding, although rare, can be life threatening and often requires advanced therapeutic interventional pulmonary procedures which are not widely available. Minor bleeding can negatively impact outcomes such as diagnostic yield, sample size and bronchoscopy duration. Both adrenaline and tranexamic acid are successfully used topically for hemostasis during diagnostic bronchoscopy. The aim of this study is to evaluate the efficacy of prophylactically applied adrenaline and tranexamic acid in bleeding prevention during diagnostic bronchoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
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
- •All patients undergoing diagnostic bronchoscopy with sampling (including transbronchial biopsy, endobronchial forceps biopsy, brushing, transbronchial needle aspiration)
- •Signed informed consent
排除标准
- •Any existing contraindication for diagnostic bronchoscopy
- •Coagulopathy (PV INR > 1.3)
- •Thrombocytopenia (<50x10*9 or anemia (Hgb <80 g/L)
- •DOAC, LMWH or antiplatelet drug therapy
- •Thrombophilia, history of pulmonary embolism or deep vein thrombosis
- •Contraindication for endobronchial application of adrenaline
- •Uncontrolled coronary artery disease, cerebrovascular disease or arrhythmia
- •Uncontrolled pulmonary hypertension
- •Cardiovascular decompensation
- •Severe hypoxia (PaO2 <60mmHg, SaO2 <90% with an FiO2 >=60%)
研究组 & 干预措施
Tranexamic acid
干预措施: Tranexamic acid (Drug)
Adrenaline
干预措施: Adrenaline (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number (N) of bleeding episodes / bleeding rate (%) in each group
时间窗: through study completion, an average of 1.5 years
Number of clinically relevant bleeding episodes after prophylactic application of tranexamic acid, adrenaline and placebo (0.9% NaCl)
次要结局
- Number (N) of drug applications needed for bleeding control(through study completion, an average of 1.5 years)
- Severity of bleeding after prophylaxis(through study completion, an average of 1.5 years)
- Adverse events(through study completion, an average of 1.5 years)
- Number (N) of bleeding episodes / bleeding rate (%) in each group stratified according to sampling type and indication(through study completion, an average of 1.5 years)
- Number (N) of samples taken in each group(through study completion, an average of 1.5 years)
研究者
Goran Glodić
MD
Clinical Hospital Centre Zagreb