An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Massive Hemoptysis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Early hemoptysis recurrence rate
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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）
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Early hemoptysis recurrence rate
Time Frame: 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
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)