ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    Swiss Liver Venous Thrombosis
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01983059
Recruitment Status : Recruiting
First Posted : November 13, 2013
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
Foundation for Liver Research
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:
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.

Condition or disease
Observational Study

Detailed 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


Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Prospective Observational Cohort Study
Study Start Date : March 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Patients with Liver Venous Thrombosis



Primary Outcome Measures :
  1. Number of patients with liver venous thrombosis recanalization [ Time Frame: End of study, expected to be on average after 5 years ]

Secondary Outcome Measures :
  1. Number of patient with thrombosis recurrence and progression [ Time Frame: End of study, expected to be on average after 5 years ]
  2. Overall mortality [ Time Frame: End of study, expected to be on average after 5 years ]
  3. Number of patients with major bleeding [ Time Frame: End of study, expected to be on average after 5 years ]
  4. Number of patients with ascites [ Time Frame: End of study, expected to be on average after 5 years ]

Biospecimen Retention:   Samples With DNA
blood, serum, plasma, stool and urine samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
All Liver Venous Thrombosis patients in participating hospitals in Switzerland
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 Idiopathy 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983059


Contacts
Contact: Andrea De Gottardi, Prof. Dr. med. 031 632 38 13 andrea.degottardi@insel.ch

Locations
Switzerland
Klinik für Gastroenterologie und Hepatologie, Universtätsspital Basel Recruiting
Basel, Kanton Basel, Switzerland, 4031
Department of Clinical Research, Hepatology Research Group Recruiting
Bern, Kanton Bern, Switzerland, 3010
Medizinische Klinik - Kantonsspital Baden Recruiting
Baden, Switzerland, 5404
Service de Gastro-entérologie et Hépatologie, Hôpitaux Universtaires de Genève Not yet recruiting
Geneva, Switzerland, 1211
Service de Gastroentérologie et d'Hépatologie, Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland, 1011
Centro di Epatologia - Clinica Luganese Moncucco Recruiting
Lugano, Switzerland, 6900
Klinik für Gastroenterologie/Hepatologie, Kantonsspital St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Klinik für Gastroenterologie und Hepatologie Universitätsspital Zürich Not yet recruiting
Zürich, Switzerland, 8091
Sponsors and Collaborators
University Hospital Inselspital, Berne
Foundation for Liver Research
Investigators
Principal Investigator: Andrea De Gottardi, Prof. Dr. med. Inselspital (University Hospital) Bern

Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT01983059     History of Changes
Other Study ID Numbers: SLVTS-SASL-35
First Posted: November 13, 2013    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017