Nadroparin Versus TIPS in Cirrhotic Patients With Refractory Asymptomatic PVT

NCT06319131 | Not Yet Recruiting

• 1 other identifier: Tipharosis
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Portal Vein Thrombosis

Keywords

portal vein thrombosis; liver cirrhosis; nadroparin; transjugular intrahepatic portosystemic shunt

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• partial recanalization rate of PVT

  6 months

• Bleeding rate

  6 months

• Mortality

  6 months

Study Arms (2)

TIPS group

EXPERIMENTAL

The cirrhotic patients with persistent PVT despite 6 months of anticoagulation therapy will receive transjugular-intrahepatic-portosystemic shunt.

Procedure: TIPS

Nadroparin group

ACTIVE COMPARATOR

The cirrhotic patients with persistent PVT despite 6 months of anticoagulation therapy will continue with the nadroparin therapy

Drug: Nadroparin

Interventions

TIPS PROCEDURE

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.

TIPS group

Nadroparin DRUG

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

Nadroparin group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Shanghai 6th People's Hospital: collaborator
• ShuGuang Hospital: collaborator
• Tongji Hospital: collaborator
• Renmin Hospital of Wuhan University: collaborator

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Portasystemic Shunt, Transjugular Intrahepatic; Nadroparin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Jian Wang, MD

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie CHEN, MD

CONTACT

8613764633539; chen.jie5@zs-hospital.sh.cn

Lili Liu, MD

CONTACT

862164041990-612632; liu.lili@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: March 19, 2024
• Study Start: May 1, 2024
• Primary Completion: May 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: March 21, 2024

Record last verified: 2024-03