Transjugular intrahepatic portosystemic shunt (TIPS) is a very effective procedure to
treat complications of portal hypertension in liver cirrhosis. TIPS implantation is
indicated in cirrhotic patients to treat or prevent portal hypertensive bleeding and to
treat refractory ascites.
During this procedure an artificial connection between portal vein and hepatic vein is
placed via an image-guided endovascular approach. Although the procedure is very
effective and reasonably safe, several complications can occur.
Due to the underlying cirrhosis, morbidity and mortality of TIPS is high, with a 30-day
mortality between 7 and 20%. Procedural site complications (transhepatic and transvenous
access), bleeding, development of hepatic encephalopathy or other organ complications and
stent complications comprise a considerable risk to the patients, however, the
improvement of mortality, renal function and liver function outweighs the risks of the
procedure. Optimal patient selection and preoperative preparation is crucial to avoid
complications of this procedure.
In liver cirrhosis, coagulation disturbances are common. In hepatic insufficiency, a
balanced reduction in the levels of most of pro- and anticoagulant proteins produced in
the liver does not impair thrombin generation until levels are quite low. However, the
ability of the coagulation system to tolerate or recover from an insult is markedly
impaired in liver disease. This allows the coagulation system to be more easily tipped
into a state favouring either haemorrhage or thrombosis. The American Gastroenterology
Association has recently published best practice advices to manage coagulation in
cirrhosis. This review concludes that commonly used global coagulation tests are not
optimal to assess the risk of bleeding in cirrhosis. A randomized controlled trial
showed, that the use of thrombelastography (TEG) to assess coagulation in cirrhosis
resulted in a significantly lower usage of blood products with no increase in bleeding
rates.
The bleeding risk for TIPS implantation is not well studied, ranging from 0.6-4.3% of
fatal bleeding complications in older uncontrolled case series. No evidenced-based
recommendations exist for the correction of coagulation abnormalities before TIPS - and
the few existing recommendations are not backed with evidence but rather "eminence
based". Currently, global tests of coagulation (prothrombin time and platelet count) are
used to guide coagulation correction. Mostly, cut-offs without sufficient evidence (PT
>50%/ INR >1.8 and platelets >50 G/L) are used for correction of coagulation.
Also, the risk of stent thrombosis needs to be considered, therefore "blind" substitution
of clotting factors or platelet transfusions is not advisable. Unfortunately, the study
by De Pietri et al. (6) did only include one patient undergoing TIPS (in the standard of
care (SOC) arm), therefore it is yet unknown, whether TEG is useful for guiding the
correction of coagulation abnormalities in cirrhosis.
The aim of this trial is to assess, whether TEG guided pre-interventional assessment and
correction of coagulation in cirrhotic patients is safe and effective
The study will be performed as a single-center, open-label, randomized prospective cohort
study