Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis

Efficacy and Safety of Nadroparin Calcium-Warfarin Sequential Anticoagulation in Portal Vein Thrombosis in Cirrhotic Patients：A Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis; Portal Vein Thrombosis
• Intervention / Treatment: Drug: Nadroparin calcium, warfarin

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Department of Gastroenterology,Qilu Hospital,Shandong University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: nadroparin calcium-warfarin sequential therapy group; nadroparin calcium every 12 hours for 1 month followed by an oral administration of warfarin for 5 months	Drug: 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.; Other Names: Experimental group
No Intervention: Control group; No anticoagulation therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recanalization Rate	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Bleeding	Risk of bleeding episodes	6 months

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Yanjing Gao, PhD.MD, Qilu Hospital，Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 20, 2019
• First Posted (Actual): November 22, 2019

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Anticoagulation; Warfarin; Portal vein thrombosis; Nadroparin calcium
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Liver Diseases; Embolism and Thrombosis; Fibrosis; Liver Cirrhosis; Thrombosis; Venous Thrombosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Calcium-Regulating Hormones and Agents; Anticoagulants; Calcium; Warfarin; Nadroparin
• Other Study ID Numbers: 2019126-QILU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No