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Open Access Study protocol

HEGPOL: Randomized, placebo controlled, multicenter, double-blind clinical trial to investigate hepatoprotective effects of glycine in the postoperative phase of liver transplantation [ISRCTN69350312]

Steffen P Luntz1, Kristina Unnebrink1, Monika Seibert-Grafe1, Hartwig Bunzendahl3, Thomas W Kraus2, Markus W Büchler2, Ernst Klar4 and Peter Schemmer2*

Author Affiliations

1 Coordination Centre for Clinical Trials (KKS), University of Heidelberg, Germany

2 Department of Surgery, University of Heidelberg, Germany

3 Department of Surgery, University of North Carolina (UNC) at Chapel Hill, USA

4 Department of Surgery, University of Rostock, Germany

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BMC Surgery 2005, 5:18  doi:10.1186/1471-2482-5-18

Published: 17 August 2005

Abstract

Background

Kupffer cell-dependent ischemia / reperfusion (I/R) injury after liver transplantation is still of high clinical relevance, as it is strongly associated with primary dysfunction and primary nonfunction of the graft. Glycine, a non-toxic, non-essential amino acid has been conclusively shown in various experiments to prevent both activation of Kupffer cells and reperfusion injury. Based on both experimental and preliminary clinical data this study protocol was designed to further evaluate the early effect of glycine after liver transplantation.

Methods / design

A prospective double-blinded randomized placebo-controlled multicenter study with two parallel groups in a total of 130 liver transplant recipients was designed to assess the effect of multiple intravenous doses of glycine after transplantation. Primary endpoints in hierarchical order are: peak levels of both aspartat-amino-transaminase (AST) and alanine-amino-transaminase (ALT) as surrogates for the progression of liver related injury, as well as both graft and patient survival up to 2 years after transplantation. Furthermore, the effect of glycine on cyclosporine A-induced nephrotoxicity is evaluated.

Discussion

The ongoing clinical trial represents an advanced element of the research chain, along which a scientific hypothesis has to go by, in order to reach the highest level of evidence; a randomized, prospective, controlled double-blinded clinical trial. If the data of this ongoing research project confirm prior findings, glycine would improve the general outcome after liver transplantation.