Safety of Anticoagulant Therapy After Tissue Glue for Gastric Varices
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the incidence of a bleeding episode from glue cast extrusion
研究概览
简要总结
This study aimed to clarify the safety of anticoagulant therapy after glue injection for cirrhotic variceal bleeding patients with portal vein thrombosis.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of cirrhosis
- •Portal hypertension with gastric varices
- •diagnosis of PVT by imaging examination
- •undergo glue injection for gastric varices
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Low molecular weight heparin (Drug)
结局指标
主要结局
the incidence of a bleeding episode from glue cast extrusion
时间窗: 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
次要结局
- death(6-month)