Plain English Summary
Background and study aims
Portal vein thrombosis (PVT) is blockage or narrowing of the portal vein (which brings blood from the intestines to the liver) by a blood clot. It is a frequent event in patients with advanced cirrhosis (scarring of the liver). When it occurs anticoagulant treatment improves the course of the disease. The aim of this study is to find out whether PVT can be prevented with the drug enoxaparin.
Who can participate?
Patients aged 18 and over with cirrhosis
What does the study involve?
Participants are randomly allocated to either be treated with enoxaparin daily for 1 year or to receive no treatment. The two groups are compared to see whether enoxaparin prevents PVT.
What are the possible benefits and risks of participating?
Enoxaparin is safe and effective at treating established PVT. Therefore, the benefits far outweigh the risks.
Where is the study run from?
University Hospital of Modena (Italy)
When is the study starting and how long is it expected to run for?
April 2008 to August 2012
Who is funding the study?
University Hospital of Modena (Italy)
Who is the main contact?
Prof. Erica Villa
erica.villa@unimore.it
Trial website
Contact information
Type
Scientific
Primary contact
Prof Erica Villa
ORCID ID
Contact details
Via del Pozzo 71
Modena
41124
Italy
-
erica.villa@unimore.it
Additional identifiers
EudraCT number
2007-007890-22
ClinicalTrials.gov number
Protocol/serial number
EudraCT Number: 2007-007890-22
Study information
Scientific title
Prevention of portal vein thrombosis with anticoagulant therapy in patients with hepatic cirrhosis: a randomised controlled trial
Acronym
Study hypothesis
Portal vein thrombosis (PVT) in patients with advanced cirrhosis may be prevented by prophylactic doses of enoxaparin.
Ethics approval
Ethics Committee Modena, 15/10/2007, ref: AOMODEN_*IV_2007_006
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Advanced stage cirrhosis
Intervention
Experimental arm: Enoxaparin (Sanofi Aventis, Milan) subcutaneously at a dose of 4000 IU/day for 1 year.
Control arm: No treatment.
Intervention type
Drug
Phase
Not Applicable
Drug names
Enoxaparin
Primary outcome measures
Prevention of portal or mesenteric vein thrombosis
Secondary outcome measures
1. Occurrence or recurrence of liver decompensation, defined as development of ascites, PSE, portal hypertensive bleeding, spontaneous bacterial peritonitis, or systemic infection
2. Overall and transplant-free survival
Overall trial start date
01/04/2008
Overall trial end date
30/08/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age ≥18 years old
2. Cirrhosis of any etiology
3. Child-Pugh score between B7 to C10
3. No evidence of PVT or spleno-mesenteric thrombosis by ultrasound evaluation and angio-CT, hepatic, renal and coagulative evaluation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
66
Participant exclusion criteria
1. Age > 75 years
2. Ascites or porto-systemic encephalopathy (PSE) at time of enrollment or during the previous 3 months
3. History of gastrointestinal bleeding, hepatocellular carcinoma, other intra/extra-hepatic cancers, or thromboembolic disease
4. Ongoing anticoagulation, antiaggregation, or antiphospholipid antibody treatmen
5. Pregnancy or breastfeeding
6. F2 varices with red whale marks or F3 varices unless ligated
7. Platelet count < 10.000/mmc
8. Evidence of paroxysmal nocturnal hemoglobinuria (based on CD 55-CD 59 flow-cytometry); or
9. Human immunodeficiency virus (HIV) infection
Recruitment start date
01/04/2008
Recruitment end date
30/08/2012
Locations
Countries of recruitment
Italy
Trial participating centre
University Hospital of Modena (Azienda Ospedaliero-Universitaria di Modena) (Italy)
Modena
41124
Italy
Sponsor information
Organisation
University Hospital of Modena (Azienda Ospedaliero-Universitaria di Modena) (Italy)
Sponsor details
Via del Pozzo 71
Modena
41124
Italy
-
pantaleoni.monica@policlinico.mo.it
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital of Modena (Azienda Ospedaliero-Universitaria di Modena) (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22819864
Publication citations
-
Results
Villa E, Cammà C, Marietta M, Luongo M, Critelli R, Colopi S, Tata C, Zecchini R, Gitto S, Petta S, Lei B, Bernabucci V, Vukotic R, De Maria N, Schepis F, Karampatou A, Caporali C, Simoni L, Del Buono M, Zambotto B, Turola E, Fornaciari G, Schianchi S, Ferrari A, Valla D, Enoxaparin prevents portal vein thrombosis and liver decompensation in patients with advanced cirrhosis., Gastroenterology, 2012, 143, 5, 1253-60.e1-4, doi: 10.1053/j.gastro.2012.07.018.