Prevention of portal vein thrombosis with anticoagulant therapy in patients with hepatic cirrhosis
| ISRCTN | ISRCTN32383354 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32383354 |
| EudraCT/CTIS number | 2007-007890-22 |
| Secondary identifying numbers | EudraCT Number: 2007-007890-22 |
- Submission date
- 13/02/2012
- Registration date
- 21/02/2012
- Last edited
- 18/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Via del Pozzo 71
Modena
41124
Italy
| erica.villa@unimore.it |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Prevention of portal vein thrombosis with anticoagulant therapy in patients with hepatic cirrhosis: a randomised controlled trial |
| Study objectives | Portal vein thrombosis (PVT) in patients with advanced cirrhosis may be prevented by prophylactic doses of enoxaparin. |
| Ethics approval(s) | Ethics Committee Modena, 15/10/2007, ref: AOMODEN_*IV_2007_006 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Enoxaparin |
| Primary outcome measure | 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 study start date | 01/04/2008 |
| Completion date | 30/08/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 66 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2008 |
| Date of final enrolment | 30/08/2012 |
Locations
Countries of recruitment
- Italy
Study participating centre
41124
Italy
Sponsor information
Hospital/treatment centre
Via del Pozzo 71
Modena
41124
Italy
| pantaleoni.monica@policlinico.mo.it | |
| Website | http://www.policlinico.mo.it/Sito/ |
"ROR" |
https://ror.org/01hmmsr16 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2012 | Yes | No |
Editorial Notes
18/10/2017: Plain English summary added.
