Safety of Anticoagulant Therapy After Endoscopic Treatment

NCT04976543 | Completed Phase 4 DMC

• 1 other identifier: 20200202-Qilu
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

NWS group

EXPERIMENTAL

nadroparin calcium injection subcutaneously every 12 hours for 1 month and switched to warfarin orally for 5 months

Drug: nadroparin calcium-warfarin sequential anticoagulation

control group

NO INTERVENTION

no anticoagulation therapy

Interventions

nadroparin calcium-warfarin sequential anticoagulation DRUG

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.

Also known as: anticoagulation

NWS group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of cirrhosis
• Portal hypertension with esophageal and gastric varices
• diagnosis of PVT by imaging examination
• undergo endoscopic therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Liaocheng People's Hospital: collaborator
• Taian City Central Hospital: collaborator

Study Sites (1)

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Fibrosis; Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases

Study Officials

• Yanjing Gao, PhD.MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 26, 2021
• Study Start: February 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 28, 2022
• Last Updated: October 12, 2022

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)