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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04976543

Enrollment

Registered

2021-07-26

Start date

2020-02-01

Completion date

2022-06-28

Last updated

2022-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

endoscopic therapy, endoscopic variceal band ligation, warfarin, nadroparin calcium

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.

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.

Interventions

DRUGnadroparin 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026