Anticoagulation for Non-occlusive Portal Vein Thrombosis in Patients With Liver Cirrhosis: a Single Center Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Number of Participants With Portal Vein Recanalization as Assessed by Cummulative Rate
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of anticoagulation in the treatment of non-occlusive portal vein thrombosis in patients with liver cirrhosis.
详细描述
Portal vein thrombosis is a common complication of liver cirrhosis, especially at the decompensated or advanced stage. The reported prevalence was 10-25% by ultrasound. The effect of PVT on the natural history of liver cirrhosis is not clear, especially the non-occlusive PVT. According to a recent large prospective study (n=1243), the development of PVT and the progression of liver disease are two separate consequences of a common mechanism. It was hypothesized that the activation of coagulation factors in the cirrhotic liver or the portal venous system is the common mechanism for the progression of liver disease, on the one hand, and the development of PVT on the other. A recent randomized clinical trial has shown that enoxaparin therapy for 48 weeks can prevent disease progression and PVT in patients with Child class B-C cirrhosis. Besides, emerging evidences have shown that 30-50% of patients with cirrhosis and partial PVT can achieve this spontaneous recanalization. So what the role of anticoagulation played in the management of PVT in liver cirrhosis is still contraversal. Anticoagulation therapy was also shown very effective with a high recanalization rate of 42-100%. But this data was mostly derived from retrospective, non-randomized study and no well-designed randomized controlled trial has been conducted to evaluate the safety and efficacy of anticoagulation for non-occlusive PVT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent was obtained
- •liver cirrhosis
- •Non-occlusive portal vein thrombosis
- •No history of variceal bleeding or receive endoscopy or β-blocker for the prevention of patients with G3 or G2 with red marks within 3 months before enrollment
- •No plan for liver transplantation
- •Age between 18 and 70
- •Child-Pugh score ≤ 11
排除标准
- •Acute PVT
- •Fibrotic cord of PV
- •Isolated splenic vein thrombosis or isolated superior mesenteric vein thrombosis
- •Extensive superior mesenteric vein thrombosis involving the distal part
- •Known coagulation disorder besides liver cirrhosis
- •HCC or other malignant tumor
- •Patients with G2 varices with red mark or G3 but did not underwent any preventive endoscopy or β-blockers
- •Platelet count < 10×109/L
- •Receive contraceptive, anticoagulation or antiplatelet drug
- •Receiving thrombolysis treatment
- •Receiving TIPS or shunting surgery
- •Bleeding tendency
- •Recent gastrointestinal bleeding like digestive ulcer or hemorrhagic stroke
- •Severe portal hypertension，for example, refractory ascite or acute variceal bleeidng
- •Spontaneous bacterial peritonitis
- •Severe cardiovascular disorder, endocrine disorder, or mental disease
- •Major surgery within 6 months
- •History of organ transplantation
- •Pregnancy or breast-feeding
- •History of HIV
- •Poor compliance
研究组 & 干预措施
Anticoagulation
Drug: Nadroparin Calcium and Warfarin Patients will take warfarin started at a dose of 2.5mg/d and with titration of dose to maintain a target INR of 2-3,along with Nadroparin Calcium 85IU／kg，subcutaneous, q12h,for the first 5 days at least.
干预措施: Nadroparin Calcium and Warfarin (Drug)
结局指标
主要结局
Number of Participants With Portal Vein Recanalization as Assessed by Cummulative Rate
时间窗: 2 year
次要结局
- Number of Participants Who Show Improvement in Child-Pugh score > 2 Points(2 years)
- Number of Participants With Major Bleeding as Assessed by Cummulative Rate(2 years)
- Relationship between Portal Vein Recanalization and Survival Assessed by Cox's Regression Proportional Hazard Model(2 years)
- Number of Participants Who Show Improvement in MELD Score > 5 points(2 year)
- Number of Participants With Liver Decompensation as Assessed by Cummulative Rate(2)
- Number of Participants with Improved Stiffness of liver and Spleen as Assessed by Transient Elastography(2 years)
- Number of Participants with Recurrence of Thrombotic Events as Assessed by Cummulative Rate(2 years)
- Number of Participants Who still Alive at the end of trial as Assessed by Cummulative Rate(2 years)
研究者
Guohong Han
Professor
Air Force Military Medical University, China