Portal Vein Thrombosis in Cirrhosis

Cirrhosis Clinical Trial

Official title:

Portal Vein Thrombosis in Cirrhosis: A Cohort Sudy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02275585
• Other study ID #: CSPT2013628
• Status: Withdrawn
• Phase: N/A
• First received: October 21, 2014
• Last updated: August 8, 2017
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: August 2017
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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...)

Related Conditions & MeSH terms

• Budd-Chiari Syndrome
• Cirrhosis
• Fibrosis
• Hepatic Vein Thrombosis
• Liver Cirrhosis
• Thrombosis
• Venous Thrombosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival of patients with cirrhosis		12 months
Secondary	Complications related with cirrhosis	Number of patients with Complications related with cirrhosis including ascites, hepatic encephalopaty, and variceal bleeding	12 months
Secondary	Complications related with anticoagulation treatment	Number of patients with Complications related with anticoagulation treatment including any haemorragic event	12 months
Secondary	Prevalence of thrombophilic disorders in patients with Portal Vein Thrombosis	To know how many patients with Portal Vein Thrombosis have Thrombophilic disorders	12 months