Safety of Anticoagulant Therapy After Endoscopic Treatment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Initiation of NWS Anticoagulation Therapy After Oesophageal Variceal Band Ligation Was Safe in Portal Vein Thrombosis Patients With Cirrhosis and Acute Variceal Bleeding: A Multi-central Randomized Controlled Trial

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

Intervention / Treatment
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* Drug: nadroparin calcium-warfarin sequential anticoagulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NWS group<br>nadroparin calcium injection subcutaneously every 12 hours for 1 month and switched to warfarin orally for 5 months | Drug: nadroparin calcium-warfarin sequential anticoagulation<br>* The NWS therapy group were given a subcutaneous injection of nadroparin calcium every 12 hours for 1 month and switched to warfarin for 5 months. Warfarin was initiated at least 5 days before nadroparin calcium was stopped. International normalized ratio (INR) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.<br>* Other names: anticoagulation;|
| No Intervention: control group<br>no anticoagulation therapy | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoscopic therapy, endoscopic variceal band ligation, warfarin, nadroparin calcium