About this trial
This is a prospective, multicenter, observational registry study of hemoptysis in China. Hospitalized patients with active hemoptysis who undergo vascular interventional diagnosis and therapy will be consecutively enrolled from tertiary hospitals across China. Baseline clinical, imaging, angiographic, procedural, and in-hospital outcome data will be collected, and patients will be followed at 1 and 3 months and every 6 months for at least 2 years. The study aims to describe the real-world epidemiology and etiology spectrum of hemoptysis in China, evaluate short- and long-term outcomes of interventional therapy, identify independent risk factors for recurrence, and build a recurrence prediction model to support standardized diagnosis and treatment of hemoptysis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥18 years.
Clinically confirmed active hemoptysis, with a pulmonary bleeding lesion verified by chest CT/CTA, bronchoscopy, or angiography.
Hemoptysis volume >100 mL in a single episode or >300 mL per day, refractory to medical treatment.
Undergoing vascular interventional diagnosis and therapy.
Disqualifiers
Concurrent participation in an interventional clinical trial of an investigational drug or novel interventional device.
Missing contact information or inability to complete basic follow-up within 3 months (very high risk of loss to follow-up).
Bleeding originating from the upper gastrointestinal tract (hematemesis) or upper respiratory tract (nasopharyngeal bleeding).
Severe, uncorrectable coagulopathy that is an absolute contraindication to interventional procedures.
Trial population
Hospitalized adults with active hemoptysis undergoing vascular interventional diagnosis and therapy at tertiary hospitals with respiratory interventional capability in China
Trial design
Cohort
Prospective
Treatments tested in this trial
Not applicable. This is an observational patient registry. All clinical procedures (including bronchial artery embolization) are part of routine medical care and are not assigned as study intervention
Other interventionNot applicable. This is an observational patient registry. All clinical procedures (including bronchial artery embolization) are part of routine medical care and are not assigned as study interventions by the investigator.
Treatment groups
Trial outcomes
Primary outcomes
Hemoptysis recurrence within 2 years
Time to and incidence of hemoptysis recurrence (re-bleeding requiring medical attention) within 2 years after enrollment, assessed by telephone or outpatient follow-up every 6 months.
Hemoptysis-specific mortality
Death attributable to hemoptysis (e.g., asphyxia or hemorrhagic shock due to pulmonary bleeding) within 2 years after enrollment.
All-cause mortality
Death from any cause within 2 years after enrollment.
Locations
Sponsors and contacts
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Qiu Jipeng
Lead sponsor
Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University
Sponsor institution
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