Safety of Anticoagulant Therapy After Endoscopic Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Cirrhosis; Esophageal and Gastric Varices; Portal Vein Thrombosis; Anticoagulant-induced Bleeding
• Intervention / Treatment: Drug: nadroparin calcium-warfarin sequential anticoagulation

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 Type: Interventional
• Enrollment (Actual): 86
• 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:

• 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

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: NWS group; nadroparin calcium injection subcutaneously every 12 hours for 1 month and switched to warfarin orally for 5 months	Drug: nadroparin calcium-warfarin sequential anticoagulation; 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.; Other Names: anticoagulation
No Intervention: control group; no anticoagulation therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Collaborators: Liaocheng People's Hospital; Taian City Central Hospital
• Investigators: Principal Investigator: Yanjing Gao, PhD.MD, Qilu Hospital, Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): June 28, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 23, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 8, 2022
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: warfarin; endoscopic therapy; endoscopic variceal band ligation; nadroparin calcium
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Liver Diseases; Embolism and Thrombosis; Esophageal Diseases; Hypertension, Portal; Fibrosis; Hemorrhage; Liver Cirrhosis; Esophageal and Gastric Varices; 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: 20200202-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