Safety of Anticoagulant Therapy After Endoscopic Treatment

Shandong University

Status and phase: Completed; Phase 4

Conditions: Cirrhosis; Portal Vein Thrombosis; Anticoagulant-induced Bleeding; Esophageal and Gastric Varices

Treatments: Drug: nadroparin calcium-warfarin sequential anticoagulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04976543

20200202-Qilu

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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86 participants in 2 patient groups

NWS group

Experimental group

Description:

nadroparin calcium injection subcutaneously every 12 hours for 1 month and switched to warfarin orally for 5 months

Treatment:

Drug: nadroparin calcium-warfarin sequential anticoagulation

control group

No Intervention group

Description:

no anticoagulation therapy