Portal Vein Thrombosis in Cirrhosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Portal Vein Thrombosis in Cirrhosis: A Cohort Sudy

Conditions
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Hepatic Vein Thrombosis, Cirrhosis

Intervention / Treatment
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* Other: Event of portal vein thrombosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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...)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cirrhosis<br>Patients with cirrhosis will be followed looking about the event of portal vein thrombosis | Other: Event of portal vein thrombosis<br>* There is no intervention over patients. They are followed during 3 years to look after any event of portal vein thrombosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of patients with cirrhosis |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications related with cirrhosis | Number of patients with Complications related with cirrhosis including ascites, hepatic encephalopaty, and variceal bleeding | 12 months | 
| Complications related with anticoagulation treatment | Number of patients with Complications related with anticoagulation treatment including any haemorragic event | 12 months | 
| Prevalence of thrombophilic disorders in patients with Portal Vein Thrombosis | To know how many patients with Portal Vein Thrombosis have Thrombophilic disorders | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Portal vein, Thrombosis, Cirrhosis