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NCT Number: NCT07833878

Chinese Hemoptysis Registry Study (CHORE)

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.

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Key information

About this study

Background: Hemoptysis is one of the most common respiratory emergencies, with a mortality of over 75% for massive hemoptysis when untreated. Bronchial artery embolization and other vascular interventions have become first-line therapy, with immediate hemostasis rates of 70-99%. However, no nationwide standardized multicenter registry for hemoptysis exists in China; the epidemiological characteristics, etiology spectrum, individualized interventional strategies, long-term prognosis, and recurrence mechanisms of Chinese patients with hemoptysis remain unclear.

Objectives: (1) To describe the cross-sectional etiology spectrum and epidemiological characteristics of hemoptysis in China; (2) to evaluate the immediate and long-term efficacy of vascular interventional therapy, including immediate hemostasis success rate, clinical success rate, and long-term recurrence rate across different etiologies; (3) to identify independent risk factors for post-interventional recurrence using Cox regression and construct a nomogram prediction model; (4) to validate the clinical value of the "systemic-to-pulmonary shunt" hypothesis in interventional management of hemoptysis; (5) to provide high-quality evidence for standardization of interventional diagnosis and treatment of hemoptysis.

Methods: Consecutively hospitalized patients aged ≥18 years with active hemoptysis (>100 mL in a single episode or >300 mL/day) refractory to medical treatment, confirmed by chest CT/CTA, bronchoscopy, or angiography, and undergoing vascular interventional diagnosis and therapy will be enrolled. A minimum of 2500 patients will be enrolled over approximately 4 years (September 2026 to December 2030). Follow-up visits are scheduled at 1 and 3 months after discharge and every 6 months thereafter for at least 2 years, recording hemoptysis recurrence, intervention-related complications, all-cause and hemoptysis-specific death.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Able to provide written informed consent and willing to participate voluntarily.

Exclusion criteria

  • 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.
  • Known allergy to iodinated contrast agents.
  • Pregnancy or lactation.
  • Severe hepatic or renal dysfunction precluding tolerance of interventional procedures.
  • Any other condition judged by the investigator as inappropriate for participation.

Treatment and study plan

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

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 interventions by the investigator.

Primary outcomes

  1. Hemoptysis recurrence within 2 years

    Time frame: Through 2 years after enrollment.

    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.

  2. Hemoptysis-specific mortality

    Time frame: Through 2 years after enrollment.

    Death attributable to hemoptysis (e.g., asphyxia or hemorrhagic shock due to pulmonary bleeding) within 2 years after enrollment.

  3. All-cause mortality

    Time frame: Through 2 years after enrollment.

    Death from any cause within 2 years after enrollment.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Qiu Jipeng

Other

Registry information

Official study title

A Prospective, Multicenter, Observational Registry Study of the Etiology Spectrum, Interventional Management, and Long-term Outcomes of Hemoptysis in China

Acronym: CHORE

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Sep 22, 2026
Registry last updated
Sep 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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