A Multicenter Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 8
- 主要终点
- Number of patients with liver venous thrombosis recanalization
研究概览
简要总结
The Liver Venous Thrombosis Study is a prospective observational cohort study aimed at collecting clinical data, patient reported outcomes and biological samples of all patients who have been newly and previously diagnosed with liver venous thrombosis in one of the participating hospitals in- and out-patient clinics of the participating centers in Switzerland. All new patients diagnosed with liver venous thrombosis or patients who are currently being treated in one of the participating centers, will be asked to participate in the study.
详细描述
Background
Outcome measures:
Primary: Liver venous thrombosis recanalization
Secondary: Thrombosis progression, Overall mortality, Major bleeding, Ascites
Objective
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
- 否
入选标准
- •Age ≥ 18 years
- •Admitted in hospital or attend outpatient clinic
- •Objectively confirmed portal vein thrombosis and/or hepatic vein thrombosis
- •Budd-Chiari-Syndrome (BCS), Non-Cirrhotic Intrahepatic Portal Hypertension (NCIPH), Sinusoidal Obstructive Syndrome (SOS), Other Vascular Diseases (Hepatoportal Sclerosis (HC), Nodular Regenerative Hyperplasia (NRH), Obliterative Portal Venopathy (OPV) or Idiopathic Portal Hypertension (IPH))
- •Subjects willing to provide informed consent
- •Exclusion Criteria
- •Thrombosis limited to mesenteric or splenic vein
- •Inability to sign consent form
- •Follow-up not possible
- •Cardiovascular, tumoral, pulmonary comorbidity with life expectancy estimated to be less than 6 months
- •Portal vein invasion by hepatocellular carcinoma
排除标准
- 未提供
结局指标
主要结局
Number of patients with liver venous thrombosis recanalization
时间窗: End of study, expected to be on average after 5 years
次要结局
- Number of patients with ascites(End of study, expected to be on average after 5 years)
- Number of patients with major bleeding(End of study, expected to be on average after 5 years)
- Number of patient with thrombosis recurrence and progression(End of study, expected to be on average after 5 years)
- Overall mortality(End of study, expected to be on average after 5 years)