Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices
1 other identifier
observational
100
1 country
1
Brief Summary
This study aimed to clarify the safety of anticoagulant therapy after glue injection for cirrhotic variceal bleeding patients with portal vein thrombosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2022
CompletedFirst Submitted
Initial submission to the registry
February 23, 2022
CompletedFirst Posted
Study publicly available on registry
September 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2024
CompletedSeptember 19, 2022
January 1, 2022
1 year
February 23, 2022
September 15, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidence of a bleeding episode from glue cast extrusion
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 Outcomes (1)
death
6-month
Study Arms (2)
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.
Control group
No anticoagulation group.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- clinical diagnosis of cirrhosis
- Portal hypertension with gastric varices
- diagnosis of PVT by imaging examination
- undergo glue injection for gastric varices
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Qilu Hospital of Shandong Universitylead
- Shandong Provincial Hospitalcollaborator
- Taian City Central Hospitalcollaborator
Study Sites (1)
Department of Gastroenterology,Qilu Hospital,Shandong University
Jinan, Shandong, 250012, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanjing Gao, PhD.
Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2022
First Posted
September 19, 2022
Study Start
January 1, 2022
Primary Completion
January 18, 2023
Study Completion
January 18, 2024
Last Updated
September 19, 2022
Record last verified: 2022-01