Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices

Sponsor

Qilu Hospital of Shandong University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05545475

Collaborator

Shandong Provincial Hospital (Other), Taian City Central Hospital (Other)

100

Enrollment

Location

24.5

Anticipated Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anticoagulants and Bleeding Disorders Tissue Adhesion Gastric Varices Bleeding	Drug: Low molecular weight heparin

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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 18, 2023

Anticipated Study Completion Date :

Jan 18, 2024

Arms and Interventions

Arm	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: Nadroparin calcium Rivaroxiban Warfarin Enoxaparin
Control group No anticoagulation group.

Arm

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:

Nadroparin calcium

Rivaroxiban

Warfarin

Enoxaparin

Control group

No anticoagulation group.

Outcome Measures

Primary Outcome Measures

the incidence of a bleeding episode from glue cast extrusion [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