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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02275585
Other study ID # CSPT2013628
Secondary ID
Status Withdrawn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
Health authority
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Status Withdrawn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...)

Study Design


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
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