Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis

Shandong University

Status and phase: Completed; Phase 4

Conditions: Liver Cirrhosis; Portal Vein Thrombosis

Treatments: Drug: Nadroparin calcium, warfarin

Study type: Interventional

Funder types: Other

Identifiers

NCT04173429

2019126-QILU

Details and patient eligibility

About

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).

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

nadroparin calcium-warfarin sequential therapy group

Experimental group

Description:

nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months

Treatment:

Drug: Nadroparin calcium, warfarin

Control group

No Intervention group

Description:

No anticoagulation therapy.