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 (juvenile) diabetes mellitus with or without impaired renal function. Unfortunately, tra...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Proneth, Andrea [verfasserIn] Schnitzbauer, Andreas A [verfasserIn] Zeman, Florian [verfasserIn] Foerster, Johanna R [verfasserIn] Holub, Ines [verfasserIn] Arbogast, Helmut [verfasserIn] Bechstein, Wolf O [verfasserIn] Becker, Thomas [verfasserIn] Dietz, Carsten [verfasserIn] Guba, Markus [verfasserIn] Heise, Michael [verfasserIn] Jonas, Sven [verfasserIn] Kersting, Stephan [verfasserIn] Klempnauer, Jürgen [verfasserIn] Manekeller, Steffen [verfasserIn] Müller, Volker [verfasserIn] Nadalin, Silvio [verfasserIn] Nashan, Björn [verfasserIn] Pascher, Andreas [verfasserIn] Rauchfuss, Falk [verfasserIn] Ströhlein, Michael A [verfasserIn] Schemmer, Peter [verfasserIn] Schenker, Peter [verfasserIn] Thorban, Stefan [verfasserIn] Vogel, Thomas [verfasserIn] Rahmel, Axel O [verfasserIn] Viebahn, Richard [verfasserIn] Banas, Bernhard [verfasserIn] Geissler, Edward K [verfasserIn] Schlitt, Hans J [verfasserIn] Farkas, Stefan A [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2013 |
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| Übergeordnetes Werk: |
Enthalten in: Transplantation research - London : Biomed Central, 2012, 2(2013), 1 vom: 01. Juli |
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| Übergeordnetes Werk: |
volume:2 ; year:2013 ; number:1 ; day:01 ; month:07 |
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| DOI / URN: |
10.1186/2047-1440-2-12 |
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| Katalog-ID: |
SPR032215533 |
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| 245 | 1 | 0 | |a Extended pancreas donor program – the EXPAND study rationale and study protocol |
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| 520 | |a 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 registration Trial registered at: NCT01384006 | ||
| 650 | 4 | |a Pancreas transplantation |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Organ allocation |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Extended donor criteria |7 (dpeaa)DE-He213 | |
| 650 | 4 | |a Rejection |7 (dpeaa)DE-He213 | |
| 700 | 1 | |a Schnitzbauer, Andreas A |e verfasserin |4 aut | |
| 700 | 1 | |a Zeman, Florian |e verfasserin |4 aut | |
| 700 | 1 | |a Foerster, Johanna R |e verfasserin |4 aut | |
| 700 | 1 | |a Holub, Ines |e verfasserin |4 aut | |
| 700 | 1 | |a Arbogast, Helmut |e verfasserin |4 aut | |
| 700 | 1 | |a Bechstein, Wolf O |e verfasserin |4 aut | |
| 700 | 1 | |a Becker, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Dietz, Carsten |e verfasserin |4 aut | |
| 700 | 1 | |a Guba, Markus |e verfasserin |4 aut | |
| 700 | 1 | |a Heise, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Jonas, Sven |e verfasserin |4 aut | |
| 700 | 1 | |a Kersting, Stephan |e verfasserin |4 aut | |
| 700 | 1 | |a Klempnauer, Jürgen |e verfasserin |4 aut | |
| 700 | 1 | |a Manekeller, Steffen |e verfasserin |4 aut | |
| 700 | 1 | |a Müller, Volker |e verfasserin |4 aut | |
| 700 | 1 | |a Nadalin, Silvio |e verfasserin |4 aut | |
| 700 | 1 | |a Nashan, Björn |e verfasserin |4 aut | |
| 700 | 1 | |a Pascher, Andreas |e verfasserin |4 aut | |
| 700 | 1 | |a Rauchfuss, Falk |e verfasserin |4 aut | |
| 700 | 1 | |a Ströhlein, Michael A |e verfasserin |4 aut | |
| 700 | 1 | |a Schemmer, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Schenker, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Thorban, Stefan |e verfasserin |4 aut | |
| 700 | 1 | |a Vogel, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Rahmel, Axel O |e verfasserin |4 aut | |
| 700 | 1 | |a Viebahn, Richard |e verfasserin |4 aut | |
| 700 | 1 | |a Banas, Bernhard |e verfasserin |4 aut | |
| 700 | 1 | |a Geissler, Edward K |e verfasserin |4 aut | |
| 700 | 1 | |a Schlitt, Hans J |e verfasserin |4 aut | |
| 700 | 1 | |a Farkas, Stefan A |e verfasserin |4 aut | |
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10.1186/2047-1440-2-12 doi (DE-627)SPR032215533 (SPR)2047-1440-2-12-e DE-627 ger DE-627 rakwb eng 610 ASE Proneth, Andrea verfasserin aut Extended pancreas donor program – the EXPAND study rationale and study protocol 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 registration Trial registered at: NCT01384006 Pancreas transplantation (dpeaa)DE-He213 Organ allocation (dpeaa)DE-He213 Extended donor criteria (dpeaa)DE-He213 Rejection (dpeaa)DE-He213 Schnitzbauer, Andreas A verfasserin aut Zeman, Florian verfasserin aut Foerster, Johanna R verfasserin aut Holub, Ines verfasserin aut Arbogast, Helmut verfasserin aut Bechstein, Wolf O verfasserin aut Becker, Thomas verfasserin aut Dietz, Carsten verfasserin aut Guba, Markus verfasserin aut Heise, Michael verfasserin aut Jonas, Sven verfasserin aut Kersting, Stephan verfasserin aut Klempnauer, Jürgen verfasserin aut Manekeller, Steffen verfasserin aut Müller, Volker verfasserin aut Nadalin, Silvio verfasserin aut Nashan, Björn verfasserin aut Pascher, Andreas verfasserin aut Rauchfuss, Falk verfasserin aut Ströhlein, Michael A verfasserin aut Schemmer, Peter verfasserin aut Schenker, Peter verfasserin aut Thorban, Stefan verfasserin aut Vogel, Thomas verfasserin aut Rahmel, Axel O verfasserin aut Viebahn, Richard verfasserin aut Banas, Bernhard verfasserin aut Geissler, Edward K verfasserin aut Schlitt, Hans J verfasserin aut Farkas, Stefan A verfasserin aut Enthalten in Transplantation research London : Biomed Central, 2012 2(2013), 1 vom: 01. Juli (DE-627)718830733 (DE-600)2668672-7 2047-1440 nnns volume:2 year:2013 number:1 day:01 month:07 https://dx.doi.org/10.1186/2047-1440-2-12 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2 2013 1 01 07 |
| spelling |
10.1186/2047-1440-2-12 doi (DE-627)SPR032215533 (SPR)2047-1440-2-12-e DE-627 ger DE-627 rakwb eng 610 ASE Proneth, Andrea verfasserin aut Extended pancreas donor program – the EXPAND study rationale and study protocol 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 registration Trial registered at: NCT01384006 Pancreas transplantation (dpeaa)DE-He213 Organ allocation (dpeaa)DE-He213 Extended donor criteria (dpeaa)DE-He213 Rejection (dpeaa)DE-He213 Schnitzbauer, Andreas A verfasserin aut Zeman, Florian verfasserin aut Foerster, Johanna R verfasserin aut Holub, Ines verfasserin aut Arbogast, Helmut verfasserin aut Bechstein, Wolf O verfasserin aut Becker, Thomas verfasserin aut Dietz, Carsten verfasserin aut Guba, Markus verfasserin aut Heise, Michael verfasserin aut Jonas, Sven verfasserin aut Kersting, Stephan verfasserin aut Klempnauer, Jürgen verfasserin aut Manekeller, Steffen verfasserin aut Müller, Volker verfasserin aut Nadalin, Silvio verfasserin aut Nashan, Björn verfasserin aut Pascher, Andreas verfasserin aut Rauchfuss, Falk verfasserin aut Ströhlein, Michael A verfasserin aut Schemmer, Peter verfasserin aut Schenker, Peter verfasserin aut Thorban, Stefan verfasserin aut Vogel, Thomas verfasserin aut Rahmel, Axel O verfasserin aut Viebahn, Richard verfasserin aut Banas, Bernhard verfasserin aut Geissler, Edward K verfasserin aut Schlitt, Hans J verfasserin aut Farkas, Stefan A verfasserin aut Enthalten in Transplantation research London : Biomed Central, 2012 2(2013), 1 vom: 01. Juli (DE-627)718830733 (DE-600)2668672-7 2047-1440 nnns volume:2 year:2013 number:1 day:01 month:07 https://dx.doi.org/10.1186/2047-1440-2-12 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2 2013 1 01 07 |
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10.1186/2047-1440-2-12 doi (DE-627)SPR032215533 (SPR)2047-1440-2-12-e DE-627 ger DE-627 rakwb eng 610 ASE Proneth, Andrea verfasserin aut Extended pancreas donor program – the EXPAND study rationale and study protocol 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 registration Trial registered at: NCT01384006 Pancreas transplantation (dpeaa)DE-He213 Organ allocation (dpeaa)DE-He213 Extended donor criteria (dpeaa)DE-He213 Rejection (dpeaa)DE-He213 Schnitzbauer, Andreas A verfasserin aut Zeman, Florian verfasserin aut Foerster, Johanna R verfasserin aut Holub, Ines verfasserin aut Arbogast, Helmut verfasserin aut Bechstein, Wolf O verfasserin aut Becker, Thomas verfasserin aut Dietz, Carsten verfasserin aut Guba, Markus verfasserin aut Heise, Michael verfasserin aut Jonas, Sven verfasserin aut Kersting, Stephan verfasserin aut Klempnauer, Jürgen verfasserin aut Manekeller, Steffen verfasserin aut Müller, Volker verfasserin aut Nadalin, Silvio verfasserin aut Nashan, Björn verfasserin aut Pascher, Andreas verfasserin aut Rauchfuss, Falk verfasserin aut Ströhlein, Michael A verfasserin aut Schemmer, Peter verfasserin aut Schenker, Peter verfasserin aut Thorban, Stefan verfasserin aut Vogel, Thomas verfasserin aut Rahmel, Axel O verfasserin aut Viebahn, Richard verfasserin aut Banas, Bernhard verfasserin aut Geissler, Edward K verfasserin aut Schlitt, Hans J verfasserin aut Farkas, Stefan A verfasserin aut Enthalten in Transplantation research London : Biomed Central, 2012 2(2013), 1 vom: 01. Juli (DE-627)718830733 (DE-600)2668672-7 2047-1440 nnns volume:2 year:2013 number:1 day:01 month:07 https://dx.doi.org/10.1186/2047-1440-2-12 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2 2013 1 01 07 |
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10.1186/2047-1440-2-12 doi (DE-627)SPR032215533 (SPR)2047-1440-2-12-e DE-627 ger DE-627 rakwb eng 610 ASE Proneth, Andrea verfasserin aut Extended pancreas donor program – the EXPAND study rationale and study protocol 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 registration Trial registered at: NCT01384006 Pancreas transplantation (dpeaa)DE-He213 Organ allocation (dpeaa)DE-He213 Extended donor criteria (dpeaa)DE-He213 Rejection (dpeaa)DE-He213 Schnitzbauer, Andreas A verfasserin aut Zeman, Florian verfasserin aut Foerster, Johanna R verfasserin aut Holub, Ines verfasserin aut Arbogast, Helmut verfasserin aut Bechstein, Wolf O verfasserin aut Becker, Thomas verfasserin aut Dietz, Carsten verfasserin aut Guba, Markus verfasserin aut Heise, Michael verfasserin aut Jonas, Sven verfasserin aut Kersting, Stephan verfasserin aut Klempnauer, Jürgen verfasserin aut Manekeller, Steffen verfasserin aut Müller, Volker verfasserin aut Nadalin, Silvio verfasserin aut Nashan, Björn verfasserin aut Pascher, Andreas verfasserin aut Rauchfuss, Falk verfasserin aut Ströhlein, Michael A verfasserin aut Schemmer, Peter verfasserin aut Schenker, Peter verfasserin aut Thorban, Stefan verfasserin aut Vogel, Thomas verfasserin aut Rahmel, Axel O verfasserin aut Viebahn, Richard verfasserin aut Banas, Bernhard verfasserin aut Geissler, Edward K verfasserin aut Schlitt, Hans J verfasserin aut Farkas, Stefan A verfasserin aut Enthalten in Transplantation research London : Biomed Central, 2012 2(2013), 1 vom: 01. Juli (DE-627)718830733 (DE-600)2668672-7 2047-1440 nnns volume:2 year:2013 number:1 day:01 month:07 https://dx.doi.org/10.1186/2047-1440-2-12 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2 2013 1 01 07 |
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10.1186/2047-1440-2-12 doi (DE-627)SPR032215533 (SPR)2047-1440-2-12-e DE-627 ger DE-627 rakwb eng 610 ASE Proneth, Andrea verfasserin aut Extended pancreas donor program – the EXPAND study rationale and study protocol 2013 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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 registration Trial registered at: NCT01384006 Pancreas transplantation (dpeaa)DE-He213 Organ allocation (dpeaa)DE-He213 Extended donor criteria (dpeaa)DE-He213 Rejection (dpeaa)DE-He213 Schnitzbauer, Andreas A verfasserin aut Zeman, Florian verfasserin aut Foerster, Johanna R verfasserin aut Holub, Ines verfasserin aut Arbogast, Helmut verfasserin aut Bechstein, Wolf O verfasserin aut Becker, Thomas verfasserin aut Dietz, Carsten verfasserin aut Guba, Markus verfasserin aut Heise, Michael verfasserin aut Jonas, Sven verfasserin aut Kersting, Stephan verfasserin aut Klempnauer, Jürgen verfasserin aut Manekeller, Steffen verfasserin aut Müller, Volker verfasserin aut Nadalin, Silvio verfasserin aut Nashan, Björn verfasserin aut Pascher, Andreas verfasserin aut Rauchfuss, Falk verfasserin aut Ströhlein, Michael A verfasserin aut Schemmer, Peter verfasserin aut Schenker, Peter verfasserin aut Thorban, Stefan verfasserin aut Vogel, Thomas verfasserin aut Rahmel, Axel O verfasserin aut Viebahn, Richard verfasserin aut Banas, Bernhard verfasserin aut Geissler, Edward K verfasserin aut Schlitt, Hans J verfasserin aut Farkas, Stefan A verfasserin aut Enthalten in Transplantation research London : Biomed Central, 2012 2(2013), 1 vom: 01. Juli (DE-627)718830733 (DE-600)2668672-7 2047-1440 nnns volume:2 year:2013 number:1 day:01 month:07 https://dx.doi.org/10.1186/2047-1440-2-12 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2003 GBV_ILN_2014 GBV_ILN_4012 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4700 AR 2 2013 1 01 07 |
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Enthalten in Transplantation research 2(2013), 1 vom: 01. Juli volume:2 year:2013 number:1 day:01 month:07 |
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Enthalten in Transplantation research 2(2013), 1 vom: 01. Juli volume:2 year:2013 number:1 day:01 month:07 |
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Pancreas transplantation Organ allocation Extended donor criteria Rejection |
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Proneth, Andrea @@aut@@ Schnitzbauer, Andreas A @@aut@@ Zeman, Florian @@aut@@ Foerster, Johanna R @@aut@@ Holub, Ines @@aut@@ Arbogast, Helmut @@aut@@ Bechstein, Wolf O @@aut@@ Becker, Thomas @@aut@@ Dietz, Carsten @@aut@@ Guba, Markus @@aut@@ Heise, Michael @@aut@@ Jonas, Sven @@aut@@ Kersting, Stephan @@aut@@ Klempnauer, Jürgen @@aut@@ Manekeller, Steffen @@aut@@ Müller, Volker @@aut@@ Nadalin, Silvio @@aut@@ Nashan, Björn @@aut@@ Pascher, Andreas @@aut@@ Rauchfuss, Falk @@aut@@ Ströhlein, Michael A @@aut@@ Schemmer, Peter @@aut@@ Schenker, Peter @@aut@@ Thorban, Stefan @@aut@@ Vogel, Thomas @@aut@@ Rahmel, Axel O @@aut@@ Viebahn, Richard @@aut@@ Banas, Bernhard @@aut@@ Geissler, Edward K @@aut@@ Schlitt, Hans J @@aut@@ Farkas, Stefan A @@aut@@ |
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Proneth, Andrea Schnitzbauer, Andreas A Zeman, Florian Foerster, Johanna R Holub, Ines Arbogast, Helmut Bechstein, Wolf O Becker, Thomas Dietz, Carsten Guba, Markus Heise, Michael Jonas, Sven Kersting, Stephan Klempnauer, Jürgen Manekeller, Steffen Müller, Volker Nadalin, Silvio Nashan, Björn Pascher, Andreas Rauchfuss, Falk Ströhlein, Michael A Schemmer, Peter Schenker, Peter Thorban, Stefan Vogel, Thomas Rahmel, Axel O Viebahn, Richard Banas, Bernhard Geissler, Edward K Schlitt, Hans J Farkas, Stefan A |
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Extended pancreas donor program – the EXPAND study rationale and study protocol |
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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 registration Trial registered at: NCT01384006 |
| abstractGer |
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 registration Trial registered at: NCT01384006 |
| abstract_unstemmed |
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 registration Trial registered at: NCT01384006 |
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Schnitzbauer, Andreas A Zeman, Florian Foerster, Johanna R Holub, Ines Arbogast, Helmut Bechstein, Wolf O Becker, Thomas Dietz, Carsten Guba, Markus Heise, Michael Jonas, Sven Kersting, Stephan Klempnauer, Jürgen Manekeller, Steffen Müller, Volker Nadalin, Silvio Nashan, Björn Pascher, Andreas Rauchfuss, Falk Ströhlein, Michael A Schemmer, Peter Schenker, Peter Thorban, Stefan Vogel, Thomas Rahmel, Axel O Viebahn, Richard Banas, Bernhard Geissler, Edward K Schlitt, Hans J Farkas, Stefan A |
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