Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices

September 15, 2022 updated by: Qilu Hospital of Shandong University
This study aimed to clarify the safety of anticoagulant therapy after glue injection for cirrhotic variceal bleeding patients with portal vein thrombosis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Acute esophagogastric varices bleeding is a common gastroenterological emergency. And the bleeding from ruptured gastric varices is massive and difficulty to stop, even after aggressive pharmacological and conservative treatment. Even after aggressive pharmacological and conservative treatment, maintaining patients without bleeding for a long time is still a challenging clinical problem. Endoscopic tissue adhesive injection is recommended by many international guidelines for acute hemostasis and secondary prevention of gastric variceal bleeding. However, postoperative glue extrusion is inevitable, and the the rebleeding caused by glue ulcers is a problem that is often faced in clinical work. In patients with portal vein thrombosis, the need for anticoagulation and the choice of anticoagulant drugs need to be carefully evaluated in terms of risk and benefit, as the dual conflicts of thrombosis and anticoagulation are involved. At present, there is no in-depth study or consensus on the effect of anticoagulation on rebleeding after glue injection in patients with portal vein thrombosis. This study is of great significance for the treatment and prognosis of patients with gastric varices combined with portal vein thrombosis.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Department of Gastroenterology,Qilu Hospital,Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All cirrhotic patients complicated with imaging-confirmed PVT and undergoing injection of tissue adhesive for GVs from three tertiary referral hospitals (Qilu Hospital of Shandong University, Shandong Provincial Hospital, and Taian City Central Hospital) were screened.

Description

Inclusion Criteria:

  • clinical diagnosis of cirrhosis
  • Portal hypertension with gastric varices
  • diagnosis of PVT by imaging examination
  • undergo glue injection for gastric varices

Exclusion Criteria:

  • hepatocellular carcinoma or other extrahepatic malignancy
  • isolated portal cavernoma
  • treatment with TIPS, thrombolysis, thrombectomy or liver transplantation
  • previous long-term anticoagulation therapy for various reasons
  • pregnant women
  • previous endoscopic treatment of GVs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Anticoagulation group
1 mg/kg of nadroparin calcium or enoxaparin every 12 h, 5000 IU of low molecular weight heparin (LMWH) every 12 h, 20 mg of rivaroxaban once daily, or warfarin adjusted by an increase or decrease of 0.75 mg until the target international normalized ratio (INR) of 2-3 was reached.
Drug: Low molecular weight heparin
Anticoagulants were given. When using warfarin, 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:
  • Enoxaparin
  • Warfarin
  • Nadroparin calcium
  • Rivaroxiban
Control group
No anticoagulation group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of a bleeding episode from glue cast extrusion
Time Frame: 6-month
hematemesis, melena, or a ≥ 2 g drop in hemoglobin, with endoscopy-confirmed active spurting or oozing from the site of extrusion of glue casts, or an ulcer with an adherent clot or a visible vessel and no other sources of bleeding
6-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
death
Time Frame: 6-month
death from all causes of illness related to liver dysfunction
6-month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Collaborators

Shandong Provincial Hospital
Taian City Central Hospital

Investigators

  • Principal Investigator: Yanjing Gao, PhD., Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

January 18, 2023

Study Completion (Anticipated)

January 18, 2024

Study Registration Dates

First Submitted

February 23, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (Actual)

September 19, 2022

Study Record Updates

Last Update Posted (Actual)

September 19, 2022

Last Update Submitted That Met QC Criteria

September 15, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20220117-Qilu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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