Back to resultsAn Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Hemoptysis
Primary Purpose
Hemoptysis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transarterial CT angiography
Sponsored by
About this trial
This is an interventional treatment trial for Hemoptysis
Eligibility Criteria
Inclusion Criteria: Patients with massive hemoptysis（defined as more than 100mL per session or more than 300mL/day）or patients with recurrent mild to moderate hemoptysis and failed conservative treatment history 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
Sites / Locations
- Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transarterial CT angiography
Arm Description
Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis
Outcomes
Primary Outcome Measures
The accuracy rate of transarterial CT angiography in the identification of culprit vessel
The accuracy rate of transarterial CT angiography in the identification of culprit vessel
Total effective dose
The total effective dose is the sum of the effective dose delivered by CT, fluoroscopy and DSA. The effective dose delivered by CT was determined using the dose length product (expressed as mGy*cm) and subsequently converted to the ED using a suitable conversion factor (0.014 mSv mGy-1 cm-1). The effective dose delivered by fluoroscopy and DSA was determined using the dose area product (expressed as mGy*cm2) and subsequently converted to the ED using a suitable conversion factor (0.12 mSv Gy-1cm-2). The dose length product and the dose area product were acquired on radiation dose structured reports.
Early hemoptysis recurrence rate
Recurrence rate of hemoptysis within 3 months after treatment
Secondary Outcome Measures
Technical success rate
Technical success is defined as complete cessation of target blood flow confirmed by DSA
Immediate hemostasis success rate
Hemostasis rate within 24 hours after treatment
The amount of contrast agent consumed
The amount of contrast agent consumed during treatment
Full Information
NCT ID
NCT05786781
First Posted
February 20, 2023
Last Updated
March 26, 2023
Sponsor
Wuhan Union Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT05786781
Brief Title
An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Hemoptysis
Official Title
An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Hemoptysis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wuhan Union Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 hemoptysis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemoptysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transarterial CT angiography
Arm Type
Experimental
Arm Description
Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis
Intervention Type
Device
Intervention Name(s)
Transarterial CT angiography
Intervention Description
Transarterial catheter-directed CT angiography during interventional treatment of hemoptysis
Primary Outcome Measure Information:
Title
The accuracy rate of transarterial CT angiography in the identification of culprit vessel
Description
The accuracy rate of transarterial CT angiography in the identification of culprit vessel
Time Frame
Intraoperative phase
Title
Total effective dose
Description
The total effective dose is the sum of the effective dose delivered by CT, fluoroscopy and DSA. The effective dose delivered by CT was determined using the dose length product (expressed as mGy*cm) and subsequently converted to the ED using a suitable conversion factor (0.014 mSv mGy-1 cm-1). The effective dose delivered by fluoroscopy and DSA was determined using the dose area product (expressed as mGy*cm2) and subsequently converted to the ED using a suitable conversion factor (0.12 mSv Gy-1cm-2). The dose length product and the dose area product were acquired on radiation dose structured reports.
Time Frame
Intraoperative phase
Title
Early hemoptysis recurrence rate
Description
Recurrence rate of hemoptysis within 3 months after treatment
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
Technical success rate
Description
Technical success is defined as complete cessation of target blood flow confirmed by DSA
Time Frame
Intraoperative phase
Title
Immediate hemostasis success rate
Description
Hemostasis rate within 24 hours after treatment
Time Frame
24 hours after treatment
Title
The amount of contrast agent consumed
Description
The amount of contrast agent consumed during treatment
Time Frame
Intraoperative phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with massive hemoptysis（defined as more than 100mL per session or more than 300mL/day）or patients with recurrent mild to moderate hemoptysis and failed conservative treatment history
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bin Liang
Phone
+8618086006235
Email
553954881@qq.com
Facility Information:
Facility Name
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bin Liang
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Hemoptysis
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