Safety of Anticoagulant Therapy After Endoscopic Treatment

Phase 4

Completed

• Conditions: Cirrhosis; Portal Vein Thrombosis; Esophageal and Gastric Varices; Anticoagulant-induced Bleeding
• Interventions: Drug: nadroparin calcium-warfarin sequential anticoagulation

• Registration Number: NCT04976543
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

The investigators aimed to verify the efficacy and safety of nadroparin calcium warfarin sequential (NWS) anticoagulation therapy after endoscopic therapy in PVT patients with cirrhosis and AVB.

Detailed Description

Acute variceal bleeding is one of the most serious complications of liver cirrhosis and is associated with significant morbidity and mortality. Portal vein thrombosis (PVT) aggravates portal hypertension and worsens hemorrhage, which Increases the risk of endoscopic therapy, and PVT has been shown to be associated with a longer time to variceal eradication, a higher risk of variceal relapse and rebleeding. So, PVT should be treated earlier. Data regarding the safety and initiation time of anticoagulant therapy in PVT patients with variceal bleeding after endoscopic therapy is lacking. Aim of this study is to verify the efficacy and safety of NWS anticoagulation therapy in PVT patients with cirrhosis and AVB after endoscopic therapy and further to explored the appropriate initiation time of NWS anticoagulation therapy after EVL in these patients.

Study Timeline

• Status Verified: 2020-02
• Study Start: 2020-02-01
• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-23
• Study First Posted: 2021-07-26
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-28
• Last Update Submitted: 2022-10-08
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• clinical diagnosis of cirrhosis
• Portal hypertension with esophageal and gastric varices
• diagnosis of PVT by imaging examination
• undergo endoscopic therapy

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Exclusion Criteria

• older than 75 years
• uncontrolled active bleeding
• hepatocellular carcinoma or other extrahepatic malignancy
• on-going or received antithrombotic/thrombolytic treatment
• previous treatment with TIPSS
• cavernous transformation of the portal vein
• platelet count lower than 10*10 ^ 9/L, creatinine more than 170 μmol/L
• Budd-Chiari syndrome
• pregnancy or breast-feeding period
• severe cardiopulmonary diseases, severe systemic infection or sepsis
• inability to sign informed consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NWS group	nadroparin calcium-warfarin sequential anticoagulation	nadroparin calcium injection subcutaneously every 12 hours for 1 month and switched to warfarin orally for 5 months

Primary Outcome Measures

Name	Time	Method
rate of overall recanalization	6-month	the sum of the fraction of patients who had complete or partial recanalization
rate of bleeding	6-month	rates of upper gastrointestinal (GI) rebleeding, epistaxis, injection-site hemorrhage, and other bleeding events

Trial Locations

Locations (1)

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