Portal Vein Thrombosis in Cirrhosis

Withdrawn

• Conditions: Hepatic Vein Thrombosis; Cirrhosis
• Interventions: Other: Event of portal vein thrombosis

• Registration Number: NCT02275585
• Lead Sponsor: Corporacion Parc Tauli

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-01
• Study Completion: 2014-10
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-24
• Study First Posted: 2014-10-27
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-08
• Last Update Posted: 2017-08-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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...)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cirrhosis	Event of portal vein thrombosis	Patients with cirrhosis will be followed looking about the event of portal vein thrombosis

Primary Outcome Measures

Name	Time	Method
Survival of patients with cirrhosis	12 months

Secondary Outcome Measures

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