An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Massive Hemoptysis

Not Applicable

Completed

• Conditions: Hemoptysis

• Registration Number: NCT05786781
• Lead Sponsor: Wuhan Union Hospital, China

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-03-26
• Study Start: 2023-03-28
• Study First Posted: 2023-03-28
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Technical success rate	Intraoperative phase	Technical success is defined as complete cessation of target blood flow confirmed by DSA
The amount of contrast agent consumed	Intraoperative phase	The amount of contrast agent consumed during treatment
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.

Trial Locations

Locations (1)

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China