The PRAISE study: A prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of iloprost in the early postoperative period after liver transplantation (ISRCTN12622749)

A prospective, double-blinded, randomized, placebo-controlled multicenter study in a total of 365 liver transplant recipients was designed to assess the effect of intravenous iloprost after liver transplantation. Primary endpoint will be the primary graft dysfunction characterized as presentation of one or more of the following criteria: ALAT or ASAT level？>？2000 IU/ml within the first 7 postoperative days, bilirubine？≥？10 mg/dl on postoperative day 7; INR？≥？1.6 on postoperative day 7 or initial non-function. Secondary endpoints are parameters of post-transplant morbidity, like rates of infections, biliary complications, need of clotting factors or renal replacement therapy and the graft and patient survival.A well-established treatment concept to avoid graft dysfunction after liver transplantation does not exist at the moment. If the data of this research project confirm prior findings, iloprost would improve the general outcome after liver transplantation.German Clinical Trials Register: DRKS00003514. Current Controlled Trials Register: ISRCTN12622749.The incidence of primary graft dysfunction (PDF) after LT is approximately 25% within a range of 9.3 to 43.7% based on different definitions characterizing PDF [1-5]. Initial non-function (INF) develops in up to 6% of all considered cases and requires urgent retransplantation [6].Risk factors are prolonged cold ischemia time or higher degree of graft steatosis and subsequent development of severe hepatic ischemia/reperfusion injury (IRI) [5,7]. A cascade of cellular events results in microcirculatory flow disturbance. This may be distinguished as “no-flow” indicating capillary perfusion failure on the one hand, or “reflow-paradox” including activation of the leukocyte-endothelium interaction, release of toxic mediators, and impairment of the endothelial barrier on the other hand [8,9]. There are, obviously, further different factors all contributing to an insufficient function of liver grafts and its detrimental effe