Portal Vein Thrombosis in Cirrhosis: A Cohort Sudy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Survival of patients with cirrhosis
研究概览
简要总结
This study evaluates the supervivence of cirrhotic patients that develop portal vein thrombosis in comparison to cirrhotic patients that do not develop portal vein thrombosis.
详细描述
Patients newly diagnosed with portal vein thrombosis by imaging tests, that evaluate the extent and exclude tumoral origin, will be included (informed consent previously signed).
Anticoagulant treatment will be initiated according to clinical guidelines (if there is no contraindication) first with LMWH (low molecular weight heparin) and later with dicoumarin.
An abdominal CT will be performed to evaluate the extent and exclude tumoral origin; a gastroscopy to evaluate portal hypertension (and do prophylaxis if required) and thrombophilia study.
Patients will be followed by imaging and laboratory tests every 6 months; to evaluate the response to the treatment and detect any cirrhosis complication.
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
- •Cirrhosis diagnosed by liver biopsy or non-invasive methods/clinical, analytics or ultrasound usual criteria
- •Portal vein thrombosis of newly diagnosed (defined as partial or complete obstruction of splenoportal vessels objectified by imaging with/without symptomatology) ≤ 6 months.
- •Over 18 years old
- •Want to participate (informed consent)
排除标准
- •Pregnant or lactating
- •Patients with tumoral vein thrombosis or elevated alpha-fetoprotein or high suspicion of underlying neoplastic disease.
- •Thrombocytopenia < 25.000 .
- •Patients with cavernomatosis or portal vein thrombosis already known.
- •Patient refusal to participate
- •Patients already treated with anticoagulants for other diseases (atrial fibrillation, pulmonary thrombosis...)
结局指标
主要结局
Survival of patients with cirrhosis
时间窗: 12 months
次要结局
- Complications related with cirrhosis(12 months)
- Prevalence of thrombophilic disorders in patients with Portal Vein Thrombosis(12 months)
- Complications related with anticoagulation treatment(12 months)
研究者
Diana Horta-Sangenis
MD
Corporacion Parc Tauli