An interventional study of Rivaroxaban in Liver Cirrhosis, sponsored by Air Force Military Medical University, China. Status unknown at 11 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-25.
Sponsored by Air Force Military Medical University, China · Not applicable, Interventional, and Treatment
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.
1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.
This study's planned enrollment of 254 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Air Force Military Medical University, China is the lead sponsor of 172 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All inclusion criteria must be met at the time of screening:
Patients who meet the following criteria at the time of screening will be excluded:
Rivaroxaban：10mg/d for 2 years
Drug: Rivaroxaban
No anticoagulants will be used.
10mg/day, for 2 years
Also known as: Nadroparin or Enoxaparin
Transplant-free survival
Time frame: 2 years
Number of participants with all-cause rebleeding
Time frame: 2 years
Number of participants with overt hepatic encephalopathy
Time frame: 2 years
Number of participants with recurrent or worsening ascites
Perform two or more evacuative paracentesis in the following six months
Time frame: 2 years
Number of participants with shunt dysfunction
Time frame: 2 years
Effect of anticoagulation on liver function estimated by the Child-Pugh and the model for end-stage liver disease scores
Time frame: 2 years
Echocardiography findings
Time frame: 2 years
Serum levels of bacterial translocation biomarkers and proinflammatory cytokines
Time frame: 2 years
Security of anticoagulation in patients with liver cirrhosis
Number of adverse events and adverse reactions in each arm of study. History and clinical evaluation of bleeding and monitoring of hematocrit.
Time frame: 2 years
Compliance
Record of unused packaging and information about compliance in a patient diary
Time frame: 2 years
Score of Health Related Quality of Life questionnaire，for example, SF-36
Time frame: 2 years
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Air Force Military Medical University, China