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Portal Vein Thrombosis in Cirrhosis

Portal Vein Thrombosis in Cirrhosis: A Cohort Sudy

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02275585
Enrollment
0
Registered
2014-10-27
Start date
2013-10-31
Completion date
2014-10-31
Last updated
2017-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis, Hepatic Vein Thrombosis

Keywords

Portal vein, Thrombosis, Cirrhosis

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.

Interventions

OTHEREvent of portal vein thrombosis

There is no intervention over patients. They are followed during 3 years to look after any event of portal vein thrombosis

Sponsors

Corporacion Parc Tauli
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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...)

Design outcomes

Primary

MeasureTime frame
Survival of patients with cirrhosis12 months

Secondary

MeasureTime frameDescription
Complications related with cirrhosis12 monthsNumber of patients with Complications related with cirrhosis including ascites, hepatic encephalopaty, and variceal bleeding
Complications related with anticoagulation treatment12 monthsNumber of patients with Complications related with anticoagulation treatment including any haemorragic event
Prevalence of thrombophilic disorders in patients with Portal Vein Thrombosis12 monthsTo know how many patients with Portal Vein Thrombosis have Thrombophilic disorders

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026