NCT01983059

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
4 months until next milestone

Study Start

First participant enrolled

March 18, 2014

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

9.7 years

First QC Date

November 6, 2013

Last Update Submit

March 14, 2023

Conditions

Observational Study

Outcome Measures

Primary Outcomes (1)

  • Number of patients with liver venous thrombosis recanalization

    End of study, expected to be on average after 5 years

Secondary Outcomes (4)

  • Number of patient with thrombosis recurrence and progression

    End of study, expected to be on average after 5 years

  • Overall mortality

    End of study, expected to be on average after 5 years

  • Number of patients with major bleeding

    End of study, expected to be on average after 5 years

  • Number of patients with ascites

    End of study, expected to be on average after 5 years

Study Arms (1)

Patients with Liver Venous Thrombosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All Liver Venous Thrombosis patients in participating hospitals in Switzerland

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Department of Clinical Research, Hepatology Research Group

Bern, Canton of Bern, 3010, Switzerland

RECRUITING

Klinik für Gastroenterologie und Hepatologie, Universtätsspital Basel

Basel, Kanton Basel, 4031, Switzerland

RECRUITING

Medizinische Klinik - Kantonsspital Baden

Baden, 5404, Switzerland

RECRUITING

Service de Gastro-entérologie et Hépatologie, Hôpitaux Universtaires de Genève

Geneva, 1211, Switzerland

NOT YET RECRUITING

Service de Gastroentérologie et d'Hépatologie, Centre Hospitalier Universitaire Vaudois

Lausanne, 1011, Switzerland

RECRUITING

Centro di Epatologia - Clinica Luganese Moncucco

Lugano, 6900, Switzerland

RECRUITING

Klinik für Gastroenterologie/Hepatologie, Kantonsspital St. Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

Klinik für Gastroenterologie und Hepatologie Universitätsspital Zürich

Zurich, 8091, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, serum, plasma, stool and urine samples

Study Officials

  • Andrea De Gottardi, Prof. Dr. med.

    Inselspital (University Hospital) Bern

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea De Gottardi, Prof. Dr. med.

CONTACT

031 632 38 13andrea.degottardi@insel.ch

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 13, 2013

Study Start

March 18, 2014

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations

CH(8)