Extended pancreas donor program : the EXPAND study rationale and study protocol

Background: Simultaneous pancreas kidney transplantation (SPK), pancreas transplantation alone (PTA) or pancreas transplantation after kidney (PAK) are the only curative treatment options for patients with type 1 (juveni
Background: Simultaneous pancreas kidney transplantation (SPK), pancreas transplantation alone (PTA) or pancreas transplantation after kidney (PAK) are the only curative treatment options for patients with type 1 (juvenile) diabetes mellitus with or without impaired renal function. Unfortunately, transplant waiting lists for this indication are increasing because the current organ acceptability criteria are restrictive; morbidity and mortality significantly increase with time on the waitlist. Currently, only pancreas organs from donors younger than 50 years of age and with a body mass index (BMI) less than 30 are allocated for transplantation in the Eurotransplant (ET) area. To address this issue we designed a study to increase the available donor pool for these patients.
Methods/Design: This study is a prospective, multicenter (20 German centers), single blinded, non-randomized, two armed trial comparing outcome after SPK, PTA or PAK between organs with the currently allowed donor criteria versus selected organs from donors with extended criteria. Extended donor criteria are defined as organs procured from donors with a BMI of 30 to 34 or a donor age between 50 and 60 years. Immunosuppression is generally standardized using induction therapy with Myfortic, tacrolimus and low dose steroids. In principle, all patients on the waitlist for primary SPK, PTA or PAK are eligible for the clinical trial when they consent to possibly receiving an extended donor criteria organ. Patients receiving an organ meeting the current standard criteria for pancreas allocation (control arm) are compared to those receiving extended criteria organ (study arm); patients are blinded for a follow-up period of one year. The combined primary endpoint is survival of the pancreas allograft and pancreas allograft function after three months, as an early relevant outcome parameter for pancreas transplantation.
Discussion: The EXPAND Study has been initiated to investigate the hypothesis that locally allocated extended criteria organs can be transplanted with similar results compared to the currently allowed standard ET organ allocation. If our study shows a favorable comparison to standard organ allocation criteria, the morbidity and mortality for patients waiting for transplantation could be reduced in the future.
Trial registered at: NCT01384006
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Author:Andrea Proneth, Andreas A. Schnitzbauer, Florian Zeman, Johanna R. Foerster, Ines Holub, Helmut Arbogast, Wolf Otto Bechstein, Thomas Becker, Carsten Dietz, Markus Guba, Michael Heise, Sven Jonas, Stephan Kersting, Jürgen Klempnauer, Steffen Manekeller, Volker Müller, Silvio Nadalin, Björn Nashan, Andreas Pascher, Falk Rauchfuss, Michael A. Ströhlein, Peter Schemmer, Peter Schenker, Stefan Thorban, Thomas Vogel, Axel O. Rahmel, Richard Viebahn, Bernhard Banas, Edward K. Geissler, Hans J. Schlitt, Stefan A. Farkas
URN:urn:nbn:de:hebis:30:3-316657
DOI:http://dx.doi.org/10.1186/2047-1440-2-12
ISSN:2047-1440
Pubmed Id:http://www.ncbi.nlm.nih.gov/pubmed?term=23816330
Parent Title (English):Transplantation research
Publisher:BioMed Central
Place of publication:London
Document Type:Article
Language:English
Date of Publication (online):2013/07/01
Date of first Publication:2013/07/01
Publishing Institution:Universitätsbibliothek Johann Christian Senckenberg
Release Date:2013/10/01
Tag:Extended donor criteria; Organ allocation; Pancreas transplantation; Rejection
Volume:2
Issue:12
Pagenumber:8
Note:
© 2013 Proneth et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License http://creativecommons.org/licenses/by/2.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
HeBIS PPN:353221074
Institutes:Medizin
Dewey Decimal Classification:610 Medizin und Gesundheit
Sammlungen:Universitätspublikationen
Licence (German):License LogoCreative Commons - Namensnennung 2.0

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