Liver CirrhosisPRO-LIVERNCT01470547
Portal Vein Thrombosis Relevance on Liver Cirrhosis: Italian Venous Thrombotic Events Registry
An observational study of Liver Cirrhosis and Portal Vein Thrombosis, run by University of Roma La Sapienza at 2 sites in Italy.
Trial summary
The portal vein thrombosis (PVT) can complicate medical conditions like liver cirrhosis (LC), neoplasms, myeloproliferative diseases, thrombophilic genotypes, infections, inflammatory diseases, trauma and surgery. LC is an important predisposing disease and is responsible for about 20% of all cases. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver Cirrhosis, Portal Vein Thrombosis
- How many people
- 753 participants
- Where
- 2 sitesItaly
- Study dates
- Apr 2012to Dec 2017
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Liver cirrhosis patients
Who may be able to join
- Cirrhosis of any etiology and severity (including HCC)
- Signed Written Informed Consent
Who cannot join
- Extrahepatic neoplasms
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Sapienza - University of Rome
Rome, RM, 00161
Società Italiana di Medicina Interna
Rome, RM, 00161
About this study
Official title: Portal Vein Thrombosis Relevance On Liver Cirrhosis: Italian Venous Thrombotic Events Registry
The portal vein thrombosis (PVT) can complicate medical conditions like liver cirrhosis (LC), neoplasms, myeloproliferative diseases, thrombophilic genotypes, infections, inflammatory diseases, trauma and surgery. LC is an important predisposing disease and is responsible for about 20% of all cases. However, data regarding the PVT in cirrhosis are insufficient.
Early studies have shown that, in absence of hepatocellular carcinoma (HCC), the PVT can occur in approximately 10% of cirrhotic patients.
Read more
Most of studies are in support of a prevalence between 5 and 20% of patients with LC. A study in transplant recipients, has documented that in variable etiology cirrhosis, the PVT was present in 15.7% of patients, a higher percentage was found in patients with liver cancer (34.8%), while primary biliary cirrhosis (7.9%) and sclerosing cholangitis (3.6%) are less frequently complicated by PVT.
The PVT development is due to stagnation in the portal circulation, but alterations in the sense of inherited or acquired pro-coagulant may favor its appearance.
The causal association of PVT with bleeding and bowel infarction suggests that the PVT may reduce survival in cirrhosis, but data are lacking on this issue. It is also not known whether asymptomatic patients with PVT have a different survival compared to cirrhotic patients without PVT. Further studies should be conducted to clarify this issue.
Likewise, prospective studies are needed to better identify risk factors predisposing to PVT in LC patients as well as to clarify the relationship between cirrhosis severity and PVT. The impact of PVT on the natural history of cirrhosis is an issue today still debated.
The PVT not only favour life-threatening complications (gastrointestinal bleeding and mesenteric thrombosis) but could also contribute to a deterioration of liver function by reducing portal flow. Obtaining such information would be of crucial importance considering that the evidence of increased mortality related to PVT in liver cirrhosis may indicate the need for randomized controlled trials to clarify the potential effectiveness of anticoagulant therapy to improve the survival.
To this purpose it's proposed to establish an Italian register of patients with cirrhosis. In the second phase of the project is planned a 2-years follow-up program in order to assess whether the PVT be an additional risk factor for mortality or deterioration of the natural history in patients with cirrhosis.
Read the detailed description
Study Design: Prospective Longitudinal Study.
The investigators planned to assess at baseline and at scheduled follow up visits:
- Medical history collection with thrombosis risk factors evaluation;
- Clinical parameters collection;
- Upper abdomen ultrasound and portal district echo color doppler to evaluate the presence of PVT;
- Esophagogastroduodenoscopy;
- Routine blood samples collection with plasma and urine storage;
At every follow up visit will be evaluated all relevant clinical events and will be recorded all treatments received during the follow-up period.
Sample Size: The investigators plan to include in the study n = 1100 patients. The sample size was calculated assuming an expected prevalence of 18% at time zero, and in order to obtain a confidence interval 95% to prevail at time zero whose distance from the edge is less than or equal to 3%.
- Conditions
- Liver Cirrhosis, Portal Vein Thrombosis
- Keywords
- Liver Cirrhosis, Portal Vein Thrombosis, Cirrhosis Complications, Registry, Italian
- Medical subject headings
- Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
PVT prevalence
To estimate the prevalence of PVT evaluated by US with power-doppler in a cohort of patients with liver cirrhosis of any etiology and severity.
Measured: 1 year
Secondary outcomes (4)
Thrombotic Events
Occurrence of thrombotic complications (deep vein and portal vein thrombosis)
Measured: 2 years
Mortality
Overall mortality in a cohort of cirrhotic patients
Measured: 2 Years
Cirrhosis Complications
Occurence of other cirrhosis-related complications (previous refractory ascites or hepatic encephalopathy; onset or progression of oesophageal varices, ascites or refractory ascites, jaundice, onset of liver cancer, infections, spontaneous bacterial peritonitis, onset of hepato-renal or hepato-pulmonary syndrome)
Measured: 2 Years
Bleeding
Occurrence of digestive or other mjor or minor bleeding events in relation to platelet count and/or PT-INR
Measured: 2-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startApr 2012
- Primary completionApr 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe 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
- 753 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pavia
- Responsible party
- Principal investigator, Francesco Violi, University of Roma La Sapienza
- Investigators
- Francesco Violi, MD, Study chair, Divisione di Prima Clinica Medica - Sapienza University of Rome and SIMIGino R Corrazza, MD, Study chair, Fondazione IRCCS Policlinico San Matteo and SIMI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470547
- Sponsor's protocol ID
- SIMI PRO-LIVER
- Acronym
- PRO-LIVER
- Status last verified
- Mar 2018
- First submitted
- 9 Nov 2011
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
D'Amico T, Miglionico M, Cangemi R, Romiti GF, De Fabrizio B, Fasano S, Recchia F, Stefanini L, Raparelli V, Violi F, Basili S; P. R. O.-LIVER Collaborators. Neutrophil-lymphocyte ratio is associated with worse outcomes in patients with cirrhosis: insights from the PRO-LIVER Registry. Intern Emerg Med. 2025 Aug;20(5):1371-1380. doi: 10.1007/s11739-025-03955-x. Epub 2025 May 20.
PubMed 40392481Violi F, Corazza GR, Caldwell SH, Perticone F, Gatta A, Angelico M, Farcomeni A, Masotti M, Napoleone L, Vestri A, Raparelli V, Basili S; PRO-LIVER Collaborators. Portal vein thrombosis relevance on liver cirrhosis: Italian Venous Thrombotic Events Registry. Intern Emerg Med. 2016 Dec;11(8):1059-1066. doi: 10.1007/s11739-016-1416-8. Epub 2016 Mar 30.
PubMed 27026379
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portal Vein Thrombosis Relevance On Liver Cirrhosis: Italian Venous Thrombotic Events Registry
- ClinicalTrials.gov ID
- NCT01470547
- Acronym / sponsor ID
- PRO-LIVER / SIMI PRO-LIVER
- Conditions
- Liver Cirrhosis, Portal Vein Thrombosis
- Keywords
- Liver Cirrhosis, Portal Vein Thrombosis, Cirrhosis Complications, Registry, Italian
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 753 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Collaborators
- University of Pavia
- Study start
- Apr 2012
- Primary completion
- Apr 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 Nov 2011 (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 portal vein thrombosis (PVT) can complicate medical conditions like liver cirrhosis (LC), neoplasms, myeloproliferative diseases, thrombophilic genotypes, infections, inflammatory diseases, trauma and surgery. LC is an important predisposing disease and is responsible for about 20% of all cases. However, data regarding the PVT in cirrhosis are insufficient.
Early studies have shown that, in absence of hepatocellular carcinoma (HCC), the PVT can occur in approximately 10% of cirrhotic patients.
Most of studies are in support of a prevalence between 5 and 20% of patients with LC. A study in transplant recipients, has documented that in variable etiology cirrhosis, the PVT was present in 15.7% of patients, a higher percentage was found in patients with liver cancer (34.8%), while primary biliary cirrhosis (7.9%) and sclerosing cholangitis (3.6%) are less frequently complicated by PVT.
The PVT development is due to stagnation in the portal circulation, but alterations in the sense of inherited or acquired pro-coagulant may favor its appearance.
The causal association of PVT with bleeding and bowel infarction suggests that the PVT may reduce survival in cirrhosis, but data are lacking on this issue. It is also not known whether asymptomatic patients with PVT have a different survival compared to cirrhotic patients without PVT. Further studies should be conducted to clarify this issue.
Likewise, prospective studies are needed to better identify risk factors predisposing to PVT in LC patients as well as to clarify the relationship between cirrhosis severity and PVT. The impact of PVT on the natural history of cirrhosis is an issue today still debated.
The PVT not only favour life-threatening complications (gastrointestinal bleeding and mesenteric thrombosis) but could also contribute to a deterioration of liver function by reducing portal flow. Obtaining such information would be of crucial importance considering that the evidence of increased mortality related to PVT in liver cirrhosis may indicate the need for randomized controlled trials to clarify the potential effectiveness of anticoagulant therapy to improve the survival.
To this purpose it's proposed to establish an Italian register of patients with cirrhosis. In the second phase of the project is planned a 2-years follow-up program in order to assess whether the PVT be an additional risk factor for mortality or deterioration of the natural history in patients with cirrhosis.
Detailed description
Study Design: Prospective Longitudinal Study.
The investigators planned to assess at baseline and at scheduled follow up visits:
- Medical history collection with thrombosis risk factors evaluation;
- Clinical parameters collection;
- Upper abdomen ultrasound and portal district echo color doppler to evaluate the presence of PVT;
- Esophagogastroduodenoscopy;
- Routine blood samples collection with plasma and urine storage;
At every follow up visit will be evaluated all relevant clinical events and will be recorded all treatments received during the follow-up period.
Sample Size: The investigators plan to include in the study n = 1100 patients. The sample size was calculated assuming an expected prevalence of 18% at time zero, and in order to obtain a confidence interval 95% to prevail at time zero whose distance from the edge is less than or equal to 3%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver cirrhosis patients
Key inclusion criteria (2 listed)
- Cirrhosis of any etiology and severity (including HCC)
- Signed Written Informed Consent
Key exclusion criteria (1 listed)
- Extrahepatic neoplasms
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
PVT prevalence
Time frame: 1 year
To estimate the prevalence of PVT evaluated by US with power-doppler in a cohort of patients with liver cirrhosis of any etiology and severity.
4 secondary outcomes
Thrombotic Events
Time frame: 2 years
Mortality
Time frame: 2 Years
Cirrhosis Complications
Time frame: 2 Years
Bleeding
Time frame: 2-4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2018.
- Derived from this study: PubMed 40392481D'Amico T, Miglionico M, Cangemi R, Romiti GF, De Fabrizio B, Fasano S, Recchia F, Stefanini L, Raparelli V, Violi F, Basili S; P. R. O.-LIVER Collaborators. Neutrophil-lymphocyte ratio is associated with worse outcomes in patients with cirrhosis: insights from the PRO-LIVER Registry. Intern Emerg Med. 2025 Aug;20(5):1371-1380. doi: 10.1007/s11739-025-03955-x. Epub 2025 May 20.
- Derived from this study: PubMed 27026379Violi F, Corazza GR, Caldwell SH, Perticone F, Gatta A, Angelico M, Farcomeni A, Masotti M, Napoleone L, Vestri A, Raparelli V, Basili S; PRO-LIVER Collaborators. Portal vein thrombosis relevance on liver cirrhosis: Italian Venous Thrombotic Events Registry. Intern Emerg Med. 2016 Dec;11(8):1059-1066. doi: 10.1007/s11739-016-1416-8. Epub 2016 Mar 30.
- Società Italiana di Medicina InternaLink provided by the sponsor.
- Preliminary dataLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Francesco Violi, MD study chair
Divisione di Prima Clinica Medica - Sapienza University of Rome and SIMI
Gino R Corrazza, MD study chair
Fondazione IRCCS Policlinico San Matteo and SIMI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Portal Vein Thrombosis, run by University of Roma La Sapienza at 2 sites in Italy.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
PVT prevalence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01470547, which also lists 2 linked publications.
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 14 Mar 2018.