Nadroparin Versus TIPS in Cirrhotic Patients With Refractory Asymptomatic PVT

Comparative Effectiveness of Nadroparin Versus Transjugular Intrahepatic Portosystemic Shunt in Cirrhotic Patients With Refractory Asymptomatic Portal Vein Thrombosis：a Multicenter, Randomized Controlled Trial

The purpose of this study is to evaluate the comparative effectiveness of nadroparin versus transjugular intrahepatic portosystemic shunt in cirrhotic patients with refractory asymptomatic portal vein thrombosis using a design of a multicenter, randomized controlled trial

Study Overview

• Status: Not yet recruiting
• Conditions: Portal Vein Thrombosis
• Intervention / Treatment: Drug: Nadroparin; Procedure: TIPS

Detailed Description

This research project aims to investigate the efficacy and safety of anticoagulant therapy in patients with portal vein thrombosis (PVT) associated with liver cirrhosis. Building upon this, a randomized controlled study will be carried out for PVT patients with poor response to anticoagulant treatment. The study will compare the effects of transjugular intrahepatic portosystemic shunt (TIPS) and prolonged anticoagulant therapy. The ultimate goal is to provide high-quality clinical research evidence for interventional treatment of liver cirrhosis-associated PVT. This comprehensive approach aims to provide evidence-based medical guidance for optimizing the treatment pathway for refractory PVT in liver cirrhosis.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie CHEN, MD; Phone Number: 8613764633539; Email: chen.jie5@zs-hospital.sh.cn
• Study Contact Backup: Name: Lili Liu, MD; Phone Number: 862164041990-612632; Email: liu.lili@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with liver cirrhosis
• Diagnosis of portal vein thrombosis through computed tomographic venography with a thrombus diameter exceeding 30% of the vessel diameter.
• Consent to participate in the clinical trial and the signing of an informed consent form.

Exclusion Criteria:

• Presence of acute symptoms such as fever, abdominal pain or bleeding, or of cavernous transformation
• Patients with Child-Pugh C.
• Pregnant or lactating women.
• With a history of liver cancer or other malignancy.
• Severe heart, lung diseases, or significant renal dysfunction.
• Allergies to anticoagulant medications, uncontrolled hypertension, history of cerebral hemorrhage, discovery of gastrointestinal ulcers, ulcerative colitis, subacute bacterial endocarditis, or other contraindications to anticoagulant drugs.
• On concomitant therapy of immunosuppressive drugs.
• With coagulation disorders other than liver disease.
• With active variceal bleeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TIPS group; The cirrhotic patients with persistent PVT despite 6 months of anticoagulation therapy will receive transjugular-intrahepatic-portosystemic shunt.	Procedure: TIPS; Using the transjugular approach, TIPS was created under local anesthesia. The first branch of the left or right portal vein (PV) was punctured by RUPS-100 set guided by digital subtraction angiography. After successful access into PV, direct portography was performed and all visible varices and/or concurrent spontaneous portosystemic shunts (SPSS) were embolized with coils and n-butyl cyanoacrylate. A polytetrafluoroethylene-covered stent (Viatorr Endoprosthesis, GORE and Associates, Flagstaff, Arizona, USA) with a diameter of 8 mm was implanted and fully dilated.
Active Comparator: Nadroparin group; The cirrhotic patients with persistent PVT despite 6 months of anticoagulation therapy will continue with the nadroparin therapy	Drug: Nadroparin; Nadroparin calcium will be subcutaneously injected with the dose of 85IU/kg q12h

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete recanalization rate of PVT	Enhanced abdominal CT scan will be performed to assess the recanalization of PVT. The primary outcome is the complete recanalization.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
partial recanalization rate of PVT	Enhanced abdominal CT scan will be performed to assess the recanalization of PVT. Partial recanalization is defined as decrease of PVT more than 50%.	6 months
Bleeding rate	Bleeding events related to anticoagulant therapy. Bleeding events will be further classified into major and minor according to the established criteria outlined by the International Society of Thrombosis and Haemostasis	6 months
Mortality	Survival analysis	6 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Tongji Hospital; Renmin Hospital of Wuhan University; ShuGuang Hospital; Shanghai 6th People's Hospital
• Investigators: Principal Investigator: Jian Wang, MD, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2026

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: liver cirrhosis; transjugular intrahepatic portosystemic shunt; portal vein thrombosis; nadroparin
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Nadroparin
• Other Study ID Numbers: Tipharosis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No