2026-526857-33-00Not yet recruitingPhase 2
Prevention of venous thromboembolism in cirrhotic patients with hepatocellular carcinoma
Source: EU CTIS (euclinicaltrials.eu) · Last updated 17 Sept 2026
Brief summary (registry, in English)
To explore the efficacy of prophylactic LMWH therapy in preventing thrombotic events in consecutive adult participants with cirrhosis of any etiology, CSPH, and HCC with a TTV of > or = 5 cm³, who are candidates for locoregional treatments, without evidence of thrombosis at the time of enrollment
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 11 Jun 2026
- Start date
- 1 Oct 2026
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Liver and biliary tract cancer
- EU CT number
- 2026-526857-33-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 70
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with liver cirrhosis, high pressure in the liver's blood vessels (CSPH) and liver cancer (HCC) of 5 cm³ or more, who are planned for local treatment of the tumour. It tests whether a blood thinner (LMWH) prevents blood clots.
- Age
- 18 years or older
- Sex
- Men and women can join
- Disease stage
- Liver cirrhosis of any cause, with CSPH and hepatocellular carcinoma (HCC) with a tumour volume (TTV) of 5 cm³ or more, who are candidates for locoregional treatments
- Earlier treatment
- People currently on blood-thinning (anticoagulant) therapy cannot join. No prior treatment is required.
Main reasons for not taking part
- A blood clot (venous thromboembolism) now or in the past
- Major bleeding in the past, or bleeding related to portal hypertension in the last 3 months
- Severe liver dysfunction (Child-Pugh class C) or INR above 2
- Severe kidney failure (GFR below 30 mL/min) or platelet count below 30,000/mm³
- Pregnancy or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- history of prior venous thromboembolic events
- current anticoagulant therapy
- participation in another clinical trial in which an investigational drug was administered within 30 days prior to screening or within 5 half-lives of the study drug, whichever is longer
- current or previous immune-mediated heparin-induced thrombocytopenia (HIT type II)
Other illness
- hypersensitivity to tinzaparin or to any of the excipients
- history of major bleeding defined as bleeding occurring in a critical site (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, intrauterine, or intramuscular with compartment syndrome)
- recent portal hypertension-related bleeding (< 3 months)
- evidence of venous thromboembolism event at baseline
- active malignancy other than HCC
Lab values
- international normalized ratio (INR) > 2
- congenital coagulation or platelet disorder
- severe renal failure (GFR <30 mL/min)
- platelet count <30,000/mm³
Other
- current septic endocarditis
- severe liver dysfunction (Child-Pugh class C)
- hepatic encephalopathy of a severity that precludes the ability to provide informed consent (West Haven grade ≥2)
- poor prognosis (estimated survival time of less than 12 months)
- pregnancy or breastfeeding
Who the study is looking for
- Written informed consent
- ability and willingness to comply with the protocol
- adults (≥ 18 years)
- male or female participants
- liver cirrhosis of any etiology
- CSPH
- HCC with TTV > or = 5 cm³, candidates for locoregional treatments
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Azienda Ospedaliera di Padova | Padova | Italy | Not yet recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.