Clinical Trial: Portal Vein Thrombosis in Cirrhosis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

Official Title: Portal Vein Thrombosis in Cirrhosis: A Cohort Sudy

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 Summary:

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.


Sponsor: Corporacion Parc Tauli

Current Primary Outcome: Survival of patients with cirrhosis [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complications related with cirrhosis [ Time Frame: 12 months ]
    Number of patients with Complications related with cirrhosis including ascites, hepatic encephalopaty, and variceal bleeding
  • Complications related with anticoagulation treatment [ Time Frame: 12 months ]
    Number of patients with Complications related with anticoagulation treatment including any haemorragic event
  • 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


Original Secondary Outcome: Same as current

Information By: Corporacion Parc Tauli

Dates:
Date Received: October 21, 2014
Date Started: October 2014
Date Completion: October 2017
Last Updated: October 24, 2014
Last Verified: October 2014