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Portal Vein Thrombosis in Cirrhosis

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ClinicalTrials.gov Identifier: NCT02275585
Recruitment Status : Withdrawn (other studies with more patients already publicated)
First Posted : October 27, 2014
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Diana Horta-Sangenis, 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.

Condition or disease Intervention/treatment
Hepatic Vein Thrombosis Cirrhosis Other: Event of 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.

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Portal Vein Thrombosis in Cirrhosis: A Cohort Sudy
Study Start Date : October 2013
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : October 2014


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




Primary Outcome Measures :
  1. Survival of patients with cirrhosis [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Complications related with cirrhosis [ Time Frame: 12 months ]
    Number of patients with Complications related with cirrhosis including ascites, hepatic encephalopaty, and variceal bleeding

  2. Complications related with anticoagulation treatment [ Time Frame: 12 months ]
    Number of patients with Complications related with anticoagulation treatment including any haemorragic event

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hospital care clinic
Criteria

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...)

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Responsible Party: Diana Horta-Sangenis, MD, Corporacion Parc Tauli
ClinicalTrials.gov Identifier: NCT02275585    
Other Study ID Numbers: CSPT2013628
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Keywords provided by Diana Horta-Sangenis, Corporacion Parc Tauli:
Portal vein
Thrombosis
Cirrhosis
Additional relevant MeSH terms:
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Liver Cirrhosis
Budd-Chiari Syndrome
Thrombosis
Venous Thrombosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases