Study of Tinzaparin Sodium to Prevent Venous Thromboembolism in Adults with Liver Cirrhosis and Hepatocellular Carcinoma

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What is this study about?

The study focuses on people who have liver cirrhosis and hepatocellular carcinoma, which are serious liver conditions that can increase the risk of dangerous blood clots. The blood clot problem being studied is called venous thromboembolism, a term that includes clots that form in deep veins of the legs (deep vein thrombosis) or travel to the lungs (pulmonary embolism) as well as clots in the veins around the liver and other abdominal organs (splanchnic veins). The medication tested is an injection of tinzaparin sodium, a type of low molecular weight heparin that is used to prevent clot formation. The purpose of the study is to see if this preventive injection can reduce the number of clot events in adults with these liver conditions who are about to receive local cancer treatments.

Participants will be randomly assigned to receive either the injection or a placebo and will be followed for about one year. During this time they will have regular visits where doctors check for any signs of new clots, bleeding, or worsening liver function, using simple blood tests and imaging scans when needed. Any bleeding problems will be judged using criteria from the International Society on Thrombosis and Haemostasis, and a special blood‑clotting test called ROTEM may be used to explore how the drug affects clotting. The study will record whether participants develop clots, experience bleeding, or have changes in their liver health over the follow‑up period.

1 enrollment and randomization

after you agree to take part, you will be assigned to receive either the study medication or standard care, based on the randomization process.

your eligibility will be confirmed, including verification that you have liver cirrhosis and hepatocellular carcinoma, a tumor volume of at least 5 cm³, and no existing blood clot.

2 baseline assessments

initial laboratory tests, imaging studies, and clinical evaluations will be performed to record your health status before starting the medication.

these results will serve as a reference for later comparisons.

3 start of study medication

you will receive tinzaparin sodium by injection.

the dose is 4500 iu (international units) per administration.

the injection will be given according to the study schedule and will continue for the duration of the trial, which may be up to 52 weeks.

4 regular medication administration

you will be instructed on how to self‑inject or receive the injection at a clinic, following the prescribed timing.

the study team will monitor your adherence and any side effects throughout the treatment period.

5 periodic follow‑up visits

you will attend scheduled clinic visits during the 52‑week period to evaluate for signs of blood clots, bleeding, and liver‑related events.

at each visit, blood tests and possibly imaging studies will be performed to assess safety and effectiveness.

6 assessment of outcomes

the primary outcome is whether a first venous thromboembolic event (such as deep vein thrombosis or pulmonary embolism) occurs within 52 weeks of randomization.

secondary outcomes include bleeding events, liver decompensation, and exploratory laboratory tests.

7 completion of trial

after 52 weeks, the study medication will be stopped and a final evaluation will be performed.

your data will be included in the analysis to determine the effectiveness of the prophylactic therapy.

Who Can Join the Study?

Give written informed consent, which means you agree in writing to join the study after it is explained to you.
Be able and willing to follow the study plan and attend all required visits.
Be an adult aged 18 years or older.
Be either male or female.
Have liver cirrhosis (scarring of the liver) from any cause.
Have CSPH (clinically significant portal hypertension – high blood pressure in the main vein that carries blood from the intestines to the liver).
Have HCC (hepatocellular carcinoma – a type of liver cancer) with a total tumor volume (TTV) of 5 cubic centimeters or larger, and be a candidate for locoregional treatments (therapies that target the tumor directly in the liver, such as ablation or embolization).

Who Cannot Join the Study?

Allergy to tinzaparin (the blood‑thinner being studied) or any of its inactive ingredients.
History of major bleeding, meaning bleeding in a critical place such as the brain, spine, eye, abdomen, joint, heart sac, uterus, or muscle causing a serious condition.
Bleeding from portal hypertension (high pressure in the vein that goes to the liver) within the past 3 months.
Current infection of the heart lining called septic endocarditis.
Having a blood clot in a vein (venous thromboembolism) at the start of the study.
Past history of blood clots in veins.
Already taking blood‑thinning medicines (anticoagulant therapy).
Very severe liver disease classified as Child‑Pugh class C (a score showing the liver is badly damaged).
Participation in another clinical trial with an experimental drug within the last 30 days or within five times the drug’s half‑life.
Severe brain changes from liver disease (hepatic encephalopathy) that make it impossible to give informed consent (West Haven grade 2 or higher).
Expected to live less than 12 months (poor prognosis).
Blood clotting test result (International Normalized Ratio, INR) greater than 2, indicating blood is too thin.
Born with a clotting or platelet problem (congenital coagulation or platelet disorder).
Any active cancer other than liver cancer (HCC).
Severe kidney disease with a glomerular filtration rate (GFR) less than 30 mL/min, which measures kidney function.
Very low platelet count (less than 30,000 per microliter), which are the cells that help blood clot.
Being pregnant or breastfeeding.
Current or past immune reaction called heparin‑induced thrombocytopenia (HIT type II), where heparin causes a drop in platelets.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

Site Name	City	Country	Status
Aodmhqy Odeidxbsunv dn Ppmzcs	Padua	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not yet recruiting	01.10.2026

Trial locations

Investigated Drugs:

Tinzaparin Sodium

Tinzaparin sodium is a medication that belongs to a group called low‑molecular‑weight heparins. It is given by injection under the skin. In this study it is used to help prevent blood clots from forming in patients who have liver cirrhosis and liver cancer and who are about to receive local treatments. By reducing the chance of clotting, the drug aims to keep the blood flowing normally and lower the risk of serious complications called venous thromboembolism.

Investigated Diseases:

Liver cirrhosis – A chronic condition in which long‑term damage causes scar tissue to replace healthy liver cells, gradually reducing liver function. The scarring makes the liver surface nodular and narrows its blood vessels. Over time, the liver’s ability to process nutrients, toxins, and blood flow diminishes. This can lead to fluid accumulation in the abdomen, swelling of the legs, and altered blood pressure in the portal vein. The increasing scar tissue often results in portal hypertension, a pressure rise in the main vein supplying the liver.
Hepatocellular carcinoma – A primary cancer that starts in the liver’s main cells. It most often develops in livers that have been damaged by chronic disease such as cirrhosis. The tumor expands by creating new blood vessels and infiltrating surrounding liver tissue. As it grows, it may involve nearby blood vessels and later spread to other parts of the body. The disease typically progresses from a single nodule to multiple lesions within the liver.

Trial ID:

2026-526857-33-00

Protocol code:

CIRCE

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Tinzaparin Sodium to Prevent Venous Thromboembolism in Adults with Liver Cirrhosis and Hepatocellular Carcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?