Portal Vein Thrombosis in Cirrhosis

NCT ID: NCT02275585

Last Updated: 2017-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-10-31

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.

Conditions

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Hepatic Vein Thrombosis Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cirrhosis

Patients with cirrhosis will be followed looking about the event of portal vein thrombosis

Event of portal vein thrombosis

Intervention Type OTHER

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

Interventions

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Event 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

Intervention Type OTHER

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...)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Corporacion Parc Tauli

OTHER

Sponsor Role lead

Responsible Party

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Diana Horta-Sangenis

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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CSPT2013628

Identifier Type: -

Identifier Source: org_study_id

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