Hemoptysis Clinical Trial
Official title:
An Exploratory Study on the Application of Transarterial CT Angiography in the Interventional Treatment of Hemoptysis
NCT number | NCT05786781 |
Other study ID # | UHCT22759 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2, 2023 |
Est. completion date | March 1, 2024 |
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
Status | Recruiting |
Enrollment | 30 |
Est. completion date | March 1, 2024 |
Est. primary completion date | March 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Wuhan Union Hospital, China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Intraoperative phase | |
Primary | 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. | Intraoperative phase | |
Primary | Early hemoptysis recurrence rate | Recurrence rate of hemoptysis within 3 months after treatment | 3 months after treatment | |
Secondary | Technical success rate | Technical success is defined as complete cessation of target blood flow confirmed by DSA | Intraoperative phase | |
Secondary | Immediate hemostasis success rate | Hemostasis rate within 24 hours after treatment | 24 hours after treatment | |
Secondary | The amount of contrast agent consumed | The amount of contrast agent consumed during treatment | Intraoperative phase |
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