Hepatic Vein ThrombosisNCT02275585
Portal Vein Thrombosis in Cirrhosis
An observational study of Hepatic Vein Thrombosis and Cirrhosis, run by Corporacion Parc Tauli.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Vein Thrombosis, Cirrhosis
- What is being tested?
- Event of portal vein thrombosis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Oct 2014
- 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: Hospital care clinic
Who may be able to join
- 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)
Who cannot join
- 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...)
About this study
Official title: Portal Vein Thrombosis in Cirrhosis: A Cohort Sudy
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.
Read the detailed 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.
- Conditions
- Hepatic Vein Thrombosis, Cirrhosis
- Being tested
- Event of portal vein thrombosis
- Keywords
- Portal vein, Thrombosis, Cirrhosis
- Medical subject headings
- Budd-Chiari Syndrome, Fibrosis, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Event of portal vein thrombosisOther
There is no intervention over patients. They are followed during 3 years to look after any event of portal vein thrombosis
| Study group | Role | What they receive |
|---|---|---|
| Cirrhosis | Patients with cirrhosis will be followed looking about the event of portal vein thrombosis Receives: Other: Event of portal vein thrombosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of patients with cirrhosis
Measured: 12 months
Secondary outcomes (3)
Complications related with cirrhosis
Number of patients with Complications related with cirrhosis including ascites, hepatic encephalopaty, and variceal bleeding
Measured: 12 months
Complications related with anticoagulation treatment
Number of patients with Complications related with anticoagulation treatment including any haemorragic event
Measured: 12 months
Prevalence of thrombophilic disorders in patients with Portal Vein Thrombosis
To know how many patients with Portal Vein Thrombosis have Thrombophilic disorders
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startOct 2013
- Primary completionJan 2014 (estimated)
- Study completionOct 2014 (estimated)
Why it stopped: other studies with more patients already publicated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Vein ThrombosisStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Horta-Sangenis, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275585
- Sponsor's protocol ID
- CSPT2013628
- Status last verified
- Aug 2017
- First submitted
- 21 Oct 2014
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portal Vein Thrombosis in Cirrhosis: A Cohort Sudy
- ClinicalTrials.gov ID
- NCT02275585
- Acronym / sponsor ID
- CSPT2013628
- Conditions
- Hepatic Vein Thrombosis, Cirrhosis
- Keywords
- Portal vein, Thrombosis, Cirrhosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: other studies with more patients already publicated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 27 Oct 2014 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cirrhosis | – | Other: Event of portal vein thrombosisPatients with cirrhosis will be followed looking about the event of portal vein thrombosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital care clinic
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Event of portal vein thrombosisThere is no intervention over patients. They are followed during 3 years to look after any event of portal vein thrombosis | Other | Cirrhosis |
Primary outcome
Survival of patients with cirrhosis
Time frame: 12 months
3 secondary outcomes
Complications related with cirrhosis
Time frame: 12 months
Complications related with anticoagulation treatment
Time frame: 12 months
Prevalence of thrombophilic disorders in patients with Portal Vein Thrombosis
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Vein Thrombosis and Cirrhosis, run by Corporacion Parc Tauli.
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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of patients with cirrhosis (time frame: 12 months). 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 9 Aug 2017.