Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2024-01-18

Brief Summary

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This study aimed to clarify the safety of anticoagulant therapy after glue injection for cirrhotic variceal bleeding patients with portal vein thrombosis.

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Detailed Description

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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.

Conditions

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Anticoagulants and Bleeding Disorders Tissue Adhesion Gastric Varices Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Low molecular weight heparin

Intervention Type DRUG

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.

Control group

No anticoagulation group.

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Nadroparin calcium Rivaroxiban Warfarin Enoxaparin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No