Anticoagulation for Advanced Cirrhotic Patients After TIPS
- Registration Number
- NCT03005444
- Lead Sponsor
- Air Force Military Medical University, China
- Brief Summary
Recent studies demonstrated that liver cirrhosis was associated with a hypercoagulability state. Besides, bacterial translocation plays an important role in the pathogenesis and complications in patients with decompensated cirrhosis, including infections as well as hepatic encephalopathy and hepatorenal syndrome.
A recent prospective study in a group of 70 patients with liver cirrhosis (Child B and C stages up to 10 points) who were randomized to receive enoxaparin for a year (n = 34) vs no intervention (n = 36) showed that anticoagulant treatment with enoxaparin is safe and effective, significantly reducing risk of PVT development and liver decompensation, markedly improving overall survival. This study provides exciting preliminary data regarding the potential use of prophylactic anticoagulation in improving clinical outcomes in cirrhosis, beyond the prevention of portal vein thrombosis. This study suggested that the effect was partly due to a direct effect of reducing BT and levels of proinflammatory cytokines. However, this study included few patients, was not double blind, and did not have a placebo group. Therefore, despite the spectacular results, the use of prophylactic anticoagulant therapy has not become routine practice in patients with cirrhosis and more studies are needed to assess the potential usefulness of anticoagulation in improving the prognosis of liver cirrhosis.
Transjugular intrahepatic portosystemic shunts (TIPS) are now routinely used to treat the complications of portal hypertension, such as variceal bleeding and refractory ascites. TIPS is the most effective method to prevent rebleeding, however, it is burdened with increased risk of hepatic encephalopathy and deterioration of liver function in patients with advanced cirrhosis. Notably, TIPS can not only relieve portal pressure but also can redirect the portal blood flow through the shunt directly into the systemic circulation which can cause systemic hemodynamic changes.
Given the preliminary data suggesting a beneficial effect of prophylactic anticoagulation with LMWH in cirrhotic patients, this multicenter randomized controlled study attempts to demonstrate the effect of long term LMWH therapy after TIPS on survival in cirrhotic patients with variceal bleeding.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 254
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anticoagulation Rivaroxaban Rivaroxaban：10mg/d for 2 years
- Primary Outcome Measures
Name Time Method Transplant-free survival 2 years
- Secondary Outcome Measures
Name Time Method Number of participants with all-cause rebleeding 2 years Number of participants with overt hepatic encephalopathy 2 years Number of participants with shunt dysfunction 2 years Effect of anticoagulation on liver function estimated by the Child-Pugh and the model for end-stage liver disease scores 2 years Number of participants with recurrent or worsening ascites 2 years Perform two or more evacuative paracentesis in the following six months
Compliance 2 years Record of unused packaging and information about compliance in a patient diary
Echocardiography findings 2 years Security of anticoagulation in patients with liver cirrhosis 2 years Number of adverse events and adverse reactions in each arm of study. History and clinical evaluation of bleeding and monitoring of hematocrit.
Score of Health Related Quality of Life questionnaire，for example, SF-36 2 years Serum levels of bacterial translocation biomarkers and proinflammatory cytokines 2 years
Trial Locations
- Locations (11)
Xi'an International Medical Center Hospital
🇨🇳Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
The Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital Affiliated to Southern Medical University
🇨🇳Guanzhou, Guangdong, China
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
🇨🇳Nanjing, Jiangsu, China
The first affiliated hospital of Nanchang university
🇨🇳Nanchang, Jiangxi, China
The First Affiliated Hospital, Air Force Medical University
🇨🇳Xi'an, Shaanxi, China
Provincial Hospital Affiliated to Shandong University
🇨🇳Jinan, Shandong, China
The Second Affiliated Hospital of Kunming Medical University
🇨🇳Kunming, Yunnan, China
The First Affiliated Hospital of Xinjiang Medical University
🇨🇳Ürümqi, Xinjiang, China
The First Affiliated Hospital of Zhejiang University
🇨🇳Hangzhou, Zhejiang, China