A Prospective, Multicenter, Observational Registry Study of the Etiology Spectrum, Interventional Management, and Long-term Outcomes of Hemoptysis in China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,500
- 主要终点
- Hemoptysis recurrence within 2 years
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Hemoptysis recurrence within 2 years
时间窗: 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.
Hemoptysis-specific mortality
时间窗: Through 2 years after enrollment.
Death attributable to hemoptysis (e.g., asphyxia or hemorrhagic shock due to pulmonary bleeding) within 2 years after enrollment.
All-cause mortality
时间窗: Through 2 years after enrollment.
Death from any cause within 2 years after enrollment.
次要结局
未报告次要终点
研究者
Qiu Jipeng
Physician
Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University