Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis

NCT04173429 | Completed Phase 4 Results DMC

• 1 other identifier: 2019126-QILU
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Liver Cirrhosis; Portal Vein Thrombosis

Keywords

Portal vein thrombosis; Nadroparin calcium; Warfarin; Anticoagulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Rate of Bleeding

  6 months

Study Arms (2)

nadroparin calcium-warfarin sequential therapy group

EXPERIMENTAL

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

Drug: Nadroparin calcium, warfarin

Control group

NO INTERVENTION

No anticoagulation therapy.

Interventions

Nadroparin calcium, warfarin 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.

Also known as: Experimental group

nadroparin calcium-warfarin sequential therapy 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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Nadroparin; Warfarin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Professor Gao Yanjing
• Organization: Qilu Hospital of Shandong University

gaoyanjing@sdu.edu.cn

18560086087

Study Officials

• Yanjing Gao, PhD.MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 22, 2019
• Study Start: January 1, 2017
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: March 2, 2021
• Results First Posted: March 2, 2021

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)