An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Massive Hemoptysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Early hemoptysis recurrence rate
研究概览
简要总结
This is a single-arm, exploratory study to evaluate the value of transarterial CT angiography applying Nexaris Angio-CT in the interventional treatment of massive hemoptysis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 massive hemoptysis（defined as more than 100mL per session or more than 300mL/day or with acute respiratory failure requiring mechanical ventilation or hemodynamic instability (systolic blood pressure < 90 mmHg), regardless of hemoptysis amount）
排除标准
- •Pregnancy
- •Patients with a previous history of bronchial artery embolization
- •Uncorrectable severe infection, coagulation dysfunction, organ failure or cachexia, severe contrast agent allergy, and other interventional treatment contraindications
结局指标
主要结局
Early hemoptysis recurrence rate
时间窗: 3 months after treatment
Recurrence rate of hemoptysis within 3 months after treatment
The accuracy rate of transarterial CT angiography in the identification of culprit vessel
时间窗: Intraoperative phase
The accuracy rate of transarterial CT angiography in the identification of culprit vessel, by calculating the matching rate between Angio-CT and selective angiography findings.
In-hospital clinical success
时间窗: During the postoperative hospitalization period (i.e., the period after bronchial artery embolization until discharge)
either the complete cessation of hemoptysis or a clinically significant reduction in bleeding, defined as ≤ 5 mL/24 hours of blood-tinged sputum or fresh blood during the hospitalization period.
次要结局
- Technical success rate(Intraoperative phase)
- The amount of contrast agent consumed(Intraoperative phase)
- Adverse events(Intraoperative phase and during 3 months after treatment)
- Radiation exposure(Intraoperative phase)