Condition category
Digestive System
Date applied
13/02/2012
Date assigned
21/02/2012
Last edited
18/10/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.policlinico.mo.it/Sito/

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

  1. 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.

Additional files

Editorial Notes

18/10/2017: Plain English summary added.