Discussion
AKI, ascites, bleeding, TIPS
ASCITES, BLEEDING, RECRUITMENT
There are several aspects that have been identified as possible practical and operational issues in the study, which have been partially previously discussed. Firstly, the present definition of AKI requires paying special attention to variations in renal function even within the normal range. Although this definition of AKI has been in place for several years, it still has not permeated completely to clinical practice. This could lead to a reduction in the identification of patients as possible candidates for the study and could maybe impact recruitment. In order to tackle this issue, the PI will undertake educational measures to increase the awareness of the study teams.The other main operational issue is the implantation of TIPS during follow-up in the standard of care group since frequently the strict definitions of refractory ascites and recurrent ascites are not fulfilled. In order to approach this issue, educational measures on behalf of the PI will take place to increase awareness of the need to follow the established definitions of refractory ascites and recurrent ascites. If the patient fulfills the accepted definitions of refractory ascites and recurrent ascites, TIPS placement is permitted. The cases that fulfill this indication should be discussed with the PI on a case-by-case basis before TIPS implantation. Similarly, if the patient fulfills the bleeding indications for TIPS (pre-emptive TIPS, salvage TIPS, rescue TIPS), TIPS placement is permitted during follow-up without discussion with the PI. The placement of TIPS during follow-up in the SOC will be specifically monitored by the study steering committee.