Anticoagulation for Advanced Cirrhotic Patients After TIPS
Status:
Unknown status
Trial end date:
2020-12-31
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
Air Force Military Medical University, China Fourth Military Medical University