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Completed

NCT Number: NCT04976543

Safety of Anticoagulant Therapy After Endoscopic Treatment

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Gastroenterology,Qilu Hospital,Shandong University

Jinan, Shandong, 250012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: anticoagulation

Primary outcomes

  1. rate of overall recanalization

    Time frame: 6-month

    the sum of the fraction of patients who had complete or partial recanalization

  2. rate of bleeding

    Time frame: 6-month

    rates of upper gastrointestinal (GI) rebleeding, epistaxis, injection-site hemorrhage, and other bleeding events

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

  • Liaocheng People's Hospital
  • Taian City Central Hospital

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jul 26, 2021
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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