Nadroparin Versus TIPS in Cirrhotic Patients With Refractory Asymptomatic PVT

Portal Vein Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06319131
• Other study ID #: Tipharosis
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: May 30, 2026

Study information

• Verified date: March 2024
• Source: Shanghai Zhongshan Hospital
• Contact: Jie CHEN, MD
• Phone: 8613764633539
• Email: chen.jie5[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 84
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Portal Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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.

Drug:
• Nadroparin
Nadroparin calcium will be subcutaneously injected with the dose of 85IU/kg q12h

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital	Renmin Hospital of Wuhan University, Shanghai 6th People's Hospital, ShuGuang Hospital, Tongji Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Mortality	Survival analysis	6 months