Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study
试验速览
- 阶段
- 2 期
- 发起方
- Liran Levy
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- amount of bleeding
研究概览
简要总结
Bleeding during transbronchial ro endobronchial biopsy is rather a common complication.
Mostly this is an insignificant bleeding, but in 3% of the biopsies there is a substantial amount of bleeding that requires a special treatment or follow up.
The goal of this study is to examine whether submission of tranexamic acid during the biopsy could diminish the amount of bleeding.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient that are candidates to endobronchial or transcronchial biopsy
排除标准
- •S/P MI or CVA or PE or DVT .
- •S/P thrombophilia.
- •Patients under coagulation therpay
- •Chronic Renal Failure
- •Pregnancy
研究组 & 干预措施
tranexamic acid
tranexamic acid will be administrated using the bronchoscope
干预措施: tranexamic acid (Drug)
saline
the saline will be administrated using an infusion during the biopsy.
干预措施: saline (Drug)
结局指标
主要结局
amount of bleeding
时间窗: participants will be followed for the duration of hospital stay, an expected average of one day
amount of bleedibg that will be calculated on the basis of the difference between the amount of saline that will be injected at the bronchoscopy and the blood and fluid that will be collected in the suction tank.
次要结局
- amount of erythrocytes(participants will be followed for the duration of hospital stay, an expected average of one day)
研究者
Liran Levy
Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study
Hadassah Medical Organization