Observational StudySLVTS-SASL-35NCT01983059
Swiss Liver Venous Thrombosis Study
An observational study of Observational Study, run by Insel Gruppe AG, University Hospital Bern at 8 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Observational Study
- How many people
- 500 participants
- Where
- 8 sitesSwitzerland
- Study dates
- 18 Mar 2014to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All Liver Venous Thrombosis patients in participating hospitals in Switzerland
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
Switzerland8 sites, 8 recruiting
- Recruiting
Medizinische Klinik - Kantonsspital Baden
Baden, 5404
- Recruiting
Klinik für Gastroenterologie und Hepatologie, Universtätsspital Basel
Basel, Kanton Basel, 4031
- Recruiting
Department of Clinical Research, Hepatology Research Group
Bern, Canton of Bern, 3010
- Not yet recruiting
Service de Gastro-entérologie et Hépatologie, Hôpitaux Universtaires de Genève
Geneva, 1211
- Recruiting
Service de Gastroentérologie et d'Hépatologie, Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
- Recruiting
Centro di Epatologia - Clinica Luganese Moncucco
Lugano, 6900
- Recruiting
Klinik für Gastroenterologie/Hepatologie, Kantonsspital St. Gallen
Sankt Gallen, 9007
- Recruiting
Klinik für Gastroenterologie und Hepatologie Universitätsspital Zürich
Zurich, 8091
About this study
Official title: A Multicenter Prospective Observational Cohort Study
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.
Read the 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
N/A
- Conditions
- Observational Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Liver Venous Thrombosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with liver venous thrombosis recanalization
Measured: End of study, expected to be on average after 5 years
Secondary outcomes (4)
Number of patient with thrombosis recurrence and progression
Measured: End of study, expected to be on average after 5 years
Overall mortality
Measured: End of study, expected to be on average after 5 years
Number of patients with major bleeding
Measured: End of study, expected to be on average after 5 years
Number of patients with ascites
Measured: End of study, expected to be on average after 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study start18 Mar 2014
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Observational StudyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Liver Research
- Responsible party
- Sponsor
- Investigators
- Andrea De Gottardi, Prof. Dr. med., Principal investigator, Inselspital (University Hospital) Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983059
- Sponsor's protocol ID
- SLVTS-SASL-35
- Acronym
- SLVTS-SASL-35
- Status last verified
- Mar 2023
- First submitted
- 6 Nov 2013
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT01983059
- Acronym / sponsor ID
- SLVTS-SASL-35 / SLVTS-SASL-35
- Conditions
- Observational Study
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Foundation for Liver Research
- Study start
- 18 Mar 2014 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
N/A
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Liver Venous Thrombosis | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All Liver Venous Thrombosis patients in participating hospitals in Switzerland
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with liver venous thrombosis recanalization
Time frame: End of study, expected to be on average after 5 years
4 secondary outcomes
Number of patient with thrombosis recurrence and progression
Time frame: End of study, expected to be on average after 5 years
Overall mortality
Time frame: End of study, expected to be on average after 5 years
Number of patients with major bleeding
Time frame: End of study, expected to be on average after 5 years
Number of patients with ascites
Time frame: End of study, expected to be on average after 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea De Gottardi, Prof. Dr. med. principal investigator
Inselspital (University Hospital) Bern
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Observational Study, run by Insel Gruppe AG, University Hospital Bern at 8 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea De Gottardi, Prof. Dr. med. (031 632 38 13, andrea.degottardi@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with liver venous thrombosis recanalization (time frame: End of study, expected to be on average after 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.