NCT04771923已完成不适用
Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding: a Double Blind, Randomized Controlled Trial
Clinical Hospital Centre Zagreb1 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2021年2月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm
研究概览
简要总结
Endobronchial bleeding is a relatively common complication of diagnostic bronchoscopy. Both tranexamic acid and adrenaline are used topically for the control of endobronchial bleeding. The aim of this study is to compare the efficacy of tranexamic acid with adrenaline in controlling iatrogenic endobronchial bleeding after diagnostic bronchoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
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
- •patients with endobronchial bleeding during diagnostic bronchoscopy that was not successfully controlled with cold (4°C) normal saline (3 aliquots of 5ml during 60sec)
排除标准
- •Any patient with a contraindication for diagnostic flexible bronchoscopy
- •Coagulopathy (PV INR >1.3)
- •Thrombocytopenia (<50x10^9) or anemia (hgb <80 g/L)
- •Direct oral anticoagulant, low molecular weight heparin or antiplatelet drug therapy
- •Thrombophilia, history of pulmonary embolism or deep vein thrombosis
- •Contraindication for endobronchial application of adrenaline
- •Coronary heart disease, cerebrovascular disease, history of tachyarrhythmia
- •Uncontrolled pulmonary hypertension
- •Cardiovascular decompensation
- •Severe hypoxia (PaO2 <60mmHg, SaO2 <90% with an FiO2 >=60%)
研究组 & 干预措施
Tranexamic acid
Experimental
干预措施: Tranexamic acid (Drug)
Adrenaline
Experimental
干预措施: Adrenaline (Drug)
结局指标
主要结局
Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm
时间窗: Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.
Bleeding control is assessed by the bronchoscopist by visual confirmation of clot formation.
次要结局
- Number (N) of tranexamic acid/adrenaline applications necessary to control endobronchial bleeding(Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application..)
- Number (N) of recurrent bleeding episodes after instillation of tranexamic acid/adrenaline(During the first 24 hours immediately after the individual procedure (bronchoscopy).)
- To compare number (N) of adverse events in each arm(During and up to 1 month after the procedure (bronchoscopy).)
- Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm in relation to the severity of bleeding.(Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application..)
- Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm(Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.)
研究者
Goran Glodić
MD
Clinical Hospital Centre Zagreb
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Prophylactic Tranexamic Acid Versus Adrenaline During Flexible BronchoscopyBleedingHemoptysisNCT06145191Clinical Hospital Centre Zagreb1,013
Unknown
2 期
Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled StudyBronchoscopy BiopsyNCT02219152Liran Levy120
进行中（未招募）
3 期
Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial CryobiopsyHemorrhage LungEndobronchial MassNCT06266546Youssef Yammine100
已完成
4 期
Tranexamic Acid Contribution in the Prevention of Perioperative Bleeding in Thoracic SurgeryBleedingNCT04224116University Tunis El Manar60
Enrolling By Invitation
3 期
Protest Trial: TXA vs SalineLung TransplantComplications SurgicalNCT06422273Corewell Health West94