Hemoptysis
Conditions
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
Interventions
DEVICETransarterial CT angiography
Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The accuracy rate of transarterial CT angiography in the identification of culprit vessel | 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 | 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. |
| Early hemoptysis recurrence rate | 3 months after treatment | Recurrence rate of hemoptysis within 3 months after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical success rate | Intraoperative phase | Technical success is defined as complete cessation of target blood flow confirmed by DSA |
| Adverse events | Intraoperative phase and during 3 months after treatment | AEs were monitored and classified according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. The CTCAE system grades AEs on a 5-point scale, with grade ≥ 3 denoting a serious AE. |
| Radiation exposure | Intraoperative phase | Radiation exposure data were systematically collected from structured radiation dose reports. For Angio-CT scans, radiation exposure was quantified using the volume CT dose index (CTDIvol) and dose-length product (DLP). For digital subtraction angiography (DSA) and fluoroscopy, air kerma (AK) and dose-area product (DAP) were utilized as metrics. |
| The amount of contrast agent consumed | Intraoperative phase | The amount of contrast agent consumed during treatment |
Countries
China
Outcome results
None listed