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Open Access Study protocol

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)

Erik Bärthel14*, Falk Rauchfuß14, Heike Hoyer2, Maria Breternitz3, Karin Jandt1 and Utz Settmacher14

Author Affiliations

1 Department of General, Visceral and Vascular Surgery, Jena University Hospital, Erlanger Allee 101, D-07740, Jena, Germany

2 Institute of Medical Statistics, Information Sciences and Documentation, Jena, Germany

3 Center for Clinical Studies, Jena, Germany

4 Center for Sepsis Control and Care, Jena University Hospital, Friedrich Schiller University, Jena, Germany

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BMC Surgery 2013, 13:1  doi:10.1186/1471-2482-13-1

Published: 29 January 2013

Abstract

Background

Liver graft dysfunction can deteriorate to complete organ failure and increases perioperative morbidity and mortality after liver transplantation. Therapeutic strategies reducing the rate of graft dysfunction are of current clinical relevance. One approach is the systemic application of prostaglandins, which were demonstrated to be beneficial in reducing ischemia-reperfusion injury. Preliminary data indicate a positive effect of prostacyclin analogue iloprost on allograft viability after liver transplantation. The objective of the study is to evaluate the impact of iloprost in a multi-center trial.

Methods/Design

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.

Discussion

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.

Trial Registration

German Clinical Trials Register: DRKS00003514. Current Controlled Trials Register: ISRCTN12622749.

Keywords:
Liver transplantation; Primary graft dysfunction; Initial non-function; Ischemia-reperfusion injury; Prostaglandins