Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis

Phase 4

Completed

• Conditions: Liver Cirrhosis; Portal Vein Thrombosis
• Interventions: Drug: Nadroparin calcium, warfarin

• Registration Number: NCT04173429
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

The study is aimed at evaluating the efficacy and safety of anticoagulant therapy with nadroparin calcium and warfarin in patients with portal vein thrombosis (PVT).

Detailed Description

Portal vein thrombosis (PVT) is a frequent complication of liver cirrhosis, referred to partial or complete thrombosis formed in the lumen of portal vein or/and branches of it. Currently, clinical guidelines of PVT in cirrhotic patients has not been addressed, and anticoagulant therapy of PVT patients with cirrhosis remains controversial. Although numerable studies have reported that anticoagulation therapy is effective, while a majority of them were respective and a few took control into consideration. In addition, no agreement has reached about the safety of anticoagulation. So, the efficacy and safety of anticoagulant therapy needs more prospective randomized controlled trial to be investigated.

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01-01
• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-22
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Results First Submitted: 2020-09-16
• Results First Submitted QC: 2021-03-01
• Last Update Submitted: 2021-03-01
• Results First Posted: 2021-03-02
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Age between 18 and 75 years
• Liver cirrhosis diagnosis based on clinical, laboratory, and imaging studies, and PVT diagnosed by abdominal contrast-enhanced computed tomography, contrast-enhanced MRI, or portal angiography

Exclusion Criteria

• Cavernous transformation of the portal vein
• Uncontrolled active bleeding
• Platelet count lower than 10*10^9/L
• Creatinine more than 170 mmol/L
• Ongoing or received antithrombotic/thrombolytic treatment
• Primary thrombophilia
• Budd-Chiari syndrome
• Pregnancy or breast-feeding period
• Severe cardiopulmonary diseases
• Severe systemic infection or sepsis
• Inability to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nadroparin calcium-warfarin sequential therapy group	Nadroparin calcium, warfarin	nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months

Primary Outcome Measures

Name	Time	Method
Recanalization Rate	6 months	For each venous segment, the vein and residual patent lumen were outlined at the level of the maximum thrombosis. Total lumen area and patent lumen area were calculated with commercially available software. The degree of thrombus occlusion was estimated as a percentage by thrombosis area/total lumen area×100%. The primary outcome was the overall recanalization rate, both complete and partial. Complete recanalization was referred to the complete disappearance of the thrombus in the portal vein trunk, at least one of the two intrahepatic portal vein branches, SMV and SV. Partial recanalization was defined as a more than 50% reduction of the thrombus, with the thrombus not extending to other veins.

Secondary Outcome Measures

Name	Time	Method
Rate of Bleeding	6 months	Risk of bleeding episodes

Trial Locations

Locations (1)

Department of Gastroenterology,Qilu Hospital,Shandong University; 🇨🇳 Jinan, Shandong, China