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
- 2/3 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare the efficacy of Dabigatran and enoxaparin in achieving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months.
研究概览
简要总结
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)
-
Complete history and physical examination
-
Pattern and number of decompensation
-
MELD, CTP, APRI, ALBI Score
-
Hemogram, Kidney function test, Liver function test, INR
-
Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 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.
- •CTP more than 10
- •Hepatocellular carcinoma
- •Tumoral PVT
- •Isolated gastric varices with red colour signs
- •Peptic ulcer disease with large ulcers
- •Pregnant or breastfeeding women
- •Thrombocytopenia (platelet count less than 50,000 per micro L)
- •Patients with concurrent acute kidney injury or chronic kidney disease stage 4 or 5
- •Those not giving consent for therapy.
结局指标
主要结局
To compare the efficacy of Dabigatran and enoxaparin in achieving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months.
时间窗: 6 months
次要结局
- Rate of partial and complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups(6 months)
- Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 3-months in between groups(3 months)
- Rate of recurrence of Portal Vein Thrombosis at 12 months.(12 months)
- Adverse events in both the groups till 6-months(6 months)
- Change in CTP scores and MELD scores in both the groups over 12-months(12 months)
- Variceal and non-variceal bleeding rates at 6-months and 12-months.(12 months)
- Worsening of decompensation events and new onset decompensation events in the two study groups till 12-months.(12 months)
- To define predictors of recanalisation at 6 months and rethrombosis at 12 months.(12 months)
研究者
Dr Sarthak Chanana
Institute of Liver and Biliary Sciences