Portal Vein Thrombosis in Cirrhosis

August 8, 2017 updated by: Diana Horta-Sangenis, Corporacion Parc Tauli

Portal Vein Thrombosis in Cirrhosis: A Cohort Sudy

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Hospital care clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cirrhosis
Patients with cirrhosis will be followed looking about the event of portal vein thrombosis
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival of patients with cirrhosis
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications related with cirrhosis
Time Frame: 12 months
Number of patients with Complications related with cirrhosis including ascites, hepatic encephalopaty, and variceal bleeding
12 months
Complications related with anticoagulation treatment
Time Frame: 12 months
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
Time Frame: 12 months
To know how many patients with Portal Vein Thrombosis have Thrombophilic disorders
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ANTICIPATED)

January 1, 2014

Study Completion (ANTICIPATED)

October 1, 2014

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

October 24, 2014

First Posted (ESTIMATE)

October 27, 2014

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPT2013628

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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