Prevention of venous thromboembolism in cirrhotic patients with hepatocellular carcinoma
Key facts
- Where
- Padova és Rome, OlaszországSee the 2 sites
- Phase
- 2. fázis
Where in Olaszország
- Azienda Ospedaliera di PadovaPadova, OlaszországToborzás még nem indult
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországToborzás még nem indult
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- EU 2026-526857-33-00
- Record updated
- 2026. szeptember 17.
- Original description
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 enrollmentRead full original descriptionShow less
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
Inclusion: 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.
Exclusion: 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); 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; international normalized ratio (INR) > 2; congenital coagulation or platelet disorder; severe renal failure (GFR <30 mL/min); platelet count <30,000/mm³; 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.