Safety of Anticoagulant Therapy After Endoscopic Treatment

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04976543
• Other study ID #: 20200202-Qilu
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2020
• Est. completion date: June 28, 2022

Study information

• Verified date: February 2020
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulant-induced Bleeding
• Cirrhosis
• Esophageal and Gastric Varices
• Fibrosis
• Hemorrhage
• Liver Cirrhosis
• Portal Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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.

Locations

Country	Name	City	State
China	Department of Gastroenterology,Qilu Hospital,Shandong University	Jinan	Shandong

Sponsors (3)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University	Liaocheng People's Hospital, Taian City Central Hospital

Country where clinical trial is conducted

China, 

Outcome

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