Swiss Liver Venous Thrombosis Study (SLVTS-SASL-35)

Insel Gruppe AG, University Hospital Bern

Status: Enrolling

Conditions: Observational Study

Study type: Observational

Funder types: Other

Identifiers

NCT01983059

SLVTS-SASL-35

Details and patient eligibility

About

The Liver Venous Thrombosis Study is a prospective observational cohort study aimed at collecting clinical data, patient reported outcomes and biological samples of all patients who have been newly and previously diagnosed with liver venous thrombosis in one of the participating hospitals in- and out-patient clinics of the participating centers in Switzerland. All new patients diagnosed with liver venous thrombosis or patients who are currently being treated in one of the participating centers, will be asked to participate in the study.

Full description

Background

Outcome measures:

Primary: Liver venous thrombosis recanalization

Secondary: Thrombosis progression, Overall mortality, Major bleeding, Ascites

Objective

• To start a prospective observational cohort study of Liver Venous Thrombosis patients in Switzerland from their primary diagnosis and already diagnosed patients.
• To examine long-term medical outcomes in patients with liver venous thrombosis in Switzerland by defining incidence, risk factors and treatment results
• To prospectively collect data on medical history, serious comorbidities, baseline clinical parameters, imaging results, pathology results, tumor characteristics, treatment, treatment outcomes, hospital stays, interventions and complications.
• To store in a biobank blood and biological samples, obtained during routine practice

Methods

N/A

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age ≥ 18 years
• Admitted in hospital or attend outpatient clinic
• Objectively confirmed portal vein thrombosis and/or hepatic vein thrombosis
• Budd-Chiari-Syndrome (BCS), Non-Cirrhotic Intrahepatic Portal Hypertension (NCIPH), Sinusoidal Obstructive Syndrome (SOS), Other Vascular Diseases (Hepatoportal Sclerosis (HC), Nodular Regenerative Hyperplasia (NRH), Obliterative Portal Venopathy (OPV) or Idiopathic Portal Hypertension (IPH))
• Subjects willing to provide informed consent

Exclusion Criteria

• Thrombosis limited to mesenteric or splenic vein
• Inability to sign consent form
• Follow-up not possible
• Cardiovascular, tumoral, pulmonary comorbidity with life expectancy estimated to be less than 6 months
• Portal vein invasion by hepatocellular carcinoma

Trial design

500 participants in 1 patient group

Patients with Liver Venous Thrombosis