Safety of Anticoagulant Therapy After Endoscopic Treatment

Sponsor

Qilu Hospital of Shandong University (Other)

Overall Status

Completed

CT.gov ID

NCT04976543

Collaborator

Liaocheng People's Hospital (Other), Taian City Central Hospital (Other)

118

Enrollment

Location

Arms

65.8

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis Portal Vein Thrombosis Esophageal and Gastric Varices Anticoagulant-induced Bleeding	Drug: nadroparin calcium-warfarin sequential anticoagulation	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Jun 28, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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