Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Incidence of venous and arterial thromboembolic events
研究概览
简要总结
Prospective single-centre, observational study with medical products. Patients with a medical history of SVT will be observed for at least 24 months after inclusion. The study will begin when the patient is referred to our centre for SVT and will end at the 24-month follow-up or at the occurrence of a study outcome event, or in case of Death OBJECTIVE: To prospectively define the incidence of recurrent thrombosis and bleeding events during anticoagulant therapy in patients with diagnosed SVT, regardless of whether they will be hospitalized or treated as outpatients
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of venous and arterial thromboembolic events
时间窗: through study completion, an average of 1 year
All venous and arterial thromboembolic (VTE and ATE) events during the study period will be registered and counted
Rate of progress /stable /regressive
时间窗: every six months, up to 2 years
To evaluate the impact of anticoagulation therapy on SVT, all enrolled patients will undergo imaging test (doppler ultrasound, contrast-enhanced CT or MR angiography).
Incidenze of bleedings events
时间窗: through study completion, an average of 1 year
Bleeding events will be classified according to ISTH definition, as follows:major bleedings,clinically relevant non-major bleedings (CRNMB), minor bleedings
incidence of liver related events
时间窗: through study completion, an average of 1 year
To evaluate the onset of liver-related events (variceal bleeding, ascites, bacterial infections, and hepatic encephalopathy), all enrolled patients will be clinically assessed
次要结局
未报告次要终点
研究者
DE STEFANO VALERIO
Full Professor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS