Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis

NCT ID: NCT04173429

Last Updated: 2021-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2020-01-31

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.

Conditions

Liver Cirrhosis; Portal Vein Thrombosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

nadroparin calcium-warfarin sequential therapy group

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

Group Type: EXPERIMENTAL

Nadroparin calcium, warfarin

Intervention Type: DRUG

Nadroparin calcium subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.

Control group

No anticoagulation therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nadroparin calcium, warfarin

Nadroparin calcium subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.

Intervention Type: DRUG

Other Intervention Names

Experimental group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yanjing Gao, PhD.MD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2019126-QILU

Identifier Type: -

Identifier Source: org_study_id