Incidence and Predictive Factors of Elective Procedure-Related Bleeding in Cirrhotic and Non-Cirrhotic Patients With Clinically Significant Portal Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Incidence of Bleeding and Adverse Events in CSPH Patients Undergoing Elective Procedures
研究概览
简要总结
Alterations in conventional coagulation tests in patients with cirrhosis and/or portal hypertension do not reliably predict bleeding risk, as hemostatic balance is complex and often compensated. Many procedure-related bleeding events are driven by non-coagulatory factors, such as portal hypertension or technical aspects of the procedure. Most commonly performed procedures carry a low risk of bleeding even in the presence of elevated INR or thrombocytopenia, and no validated laboratory thresholds support prophylactic correction. Risk assessment should therefore be based on procedural factors, severity of liver disease, and systemic patient conditions, with correction of modifiable risk factors particularly before high-risk elective procedures.
详细描述
All cirrhotic and non-cirrhotic patients with clinically significant portal hypertension undergoing elective procedures will be followed to assess the occurrence of major bleeding events and other adverse outcomes. Outcomes will include bleeding events, classified according to ISTH criteria as major, clinically relevant non-major, and minor bleeding; venous and arterial thrombotic events, diagnosed using objective methods and classified as symptomatic or incidental in accordance with ISTH recommendations; and liver-related events, including variceal bleeding, ascites, bacterial infections, and hepatic encephalopathy, clinically assessed during follow-up.
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;
- •Ability to provide informed consent;
- •Specific signs of CSPH (gastroesophageal varices, porto-systemic collaterals, liver stiffness measurement (LSM) > 25 KPa or spleen stiffness measurement (SSM) > 50 KPa);
排除标准
- •Age < 18 years;
- •Life expectancy < 6 months;
- •Patients unable to sign informed consent.
结局指标
主要结局
Incidence of Bleeding and Adverse Events in CSPH Patients Undergoing Elective Procedures
时间窗: 36-48 months
To prospectively define the incidence of bleeding and other adverse events in patients with clinically significant portal hypertension (CSPH) who undergo elective low and high risk procedures.
次要结局
未报告次要终点