NCT04976543

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 86 (actual)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-01
• Primary completion: 2021-12-31
• Completion: 2022-06-28
• First posted: 2021-07-26
• Last updated: 2022-10-12

Locations

1 site across 1 country: China