Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis: A Randomized Controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion of patients achiving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months in both groups.
研究概览
简要总结
Portal vein thrombosis (PVT) is prevalent among patients with cirrhosis, and its prevalence rises with the severity of liver disease. Numerous studies have indicated that patients developing PVT experience elevated portal pressure and associated complications, such as increased incidence of variceal bleeding, higher rates of failed variceal bleed control, rebleeding, and short-term mortality. Additionally, the development of PVT adversely affects post-transplant outcomes, correlating with increased 30-day mortality among transplant recipients with PVT. Current guidelines lack clarity regarding the optimal choice of anticoagulation therapy for patients with cirrhosis. This study aims to evaluate the efficacy and safety of enoxaparin and dabigatran in achieving complete recanalization of portal vein thrombosis in cirrhotic patients over a 6-month period.
详细描述
Study population: Cirrhosis with portal vein thrombosis within 6 months of diagnosis of portal vein thrombus Study design - A prospective, randomized, single center open label study Block Randomization, block size - 10 Study site - Department of Hepatology, ILBS, New Delhi from The study will be conducted on the consecutive patients with liver cirrhosis with portal vein thrombosis.
Study period -1 year Monitoring and assessment
- At enrollment:
- Complete history and physical examination
- Etiology of cirrhosis
- Presenting symptoms
- Severity of ascites, Jaundice
- Pattern and number of prior decompensation
- UGIE and variceal status
- Complete physical evaluation
- Hemogram, Kidney function test, Liver function test, INR
- Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen
- Fibroscan-liver and spleen
- 2D-ECHO, ECG
- AFP At follow-up (1month, 3 month, 6 month, 9 month 12month)
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
- •Age >18 years
- •Cirrhosis with portal vein thrombosis within 6 months of diagnosis/Symptomatic PVT/PVT in potential transplant recipient.
排除标准
- •Contraindications to anticoagulant therapy, such as active bleeding, recent major surgery, or known hypersensitivity to study medications.
- •Hepatocellular carcinoma
- •Tumoral PVT
- •Isolated gastric varices with red colour signs
- •Peptic ulcer disease with large ulcers
- •Pregnant or breastfeeding women
- •Thrombocytopenia (platelet count <50,000/μL)
- •Patients with concurrent acute kidney injury or chronic kidney disease stage 4 or 5
- •Those not giving consent for therapy
研究组 & 干预措施
Enoxaparin
Enoxaparin Treatment would be given with 1 mg /Kg (100IU/Kg) dose s/c twice daily for 6 months.
干预措施: Enoxaparin (Drug)
Dabigatran
Dabigatran 150 mg BD fixed dose to be given for duration of 6 months.
干预措施: Dabigatran (Drug)
结局指标
主要结局
Proportion of patients achiving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months in both groups.
时间窗: 6 months
次要结局
- Baseline parameters for predicting rethrombosis of PVT at 12 months in both the groups.(12 months)
- Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups.(6 months)
- Rate of partial recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups.(6 months)
- Rate of recurrence of Portal Vein Thrombosis at 12 months.(12 months)
- Variceal and non-variceal bleeding rates at 6-months and 12-months(6-months and 12-months)
- Baseline parameters for predicting recanalisation of Portal Vein Thrombosis (PVT) at 6 months in both the groups.(12 months)
- Adverse events in both the groups till 6-months(6 months)
- Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 3-months in between groups.(3 months)
- Change in CTP scores in both the groups over 12-months(12-months)
- Change in MELD scores in both the groups over 12-months(12-months)
- Number of patients with worsening of decompensation events and new onset decompensation events in the two study groups till 12-months(12-months)