Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Kniepeiss, D; Houben, P; Stiegler, P; Berghold, A; Riedl, R; Kahn, J; Schemmer, P.
A prospective, randomized, single-blind, multicentre, phase III study on organ preservation with Custodiol-N solution compared with Custodiol® solution in organ transplantation (kidney, liver and pancreas).
Trials. 2020; 21(1): 62-62.
Doi: 10.1186/s13063-019-3823-4
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- Führende Autor*innen der Med Uni Graz
- Kniepeiss Daniela
- Schemmer Peter
- Co-Autor*innen der Med Uni Graz
- Berghold Andrea
- Kahn Judith
- Riedl Regina
- Stiegler Philipp
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- Abstract:
- Organ preservation before transplantation is still a challenge. Both the University of Wisconsin and Bretschneider's histidine-tryptophan-ketoglutarate (HTK; Custodiol®) solution are standard for liver, kidney and pancreas preservation. Organ preservation with both solutions is comparable; recently, however, Custodiol® solution has been modified to Custodiol-N according to the needs of today. Thus, our study was defined to study its effect in clinical transplantation. Patients undergoing kidney transplantation (n = 412) (including approximately 30 combined kidney-pancreas) or liver transplantation (n = 202) receive grafts that have been cold stored in either Custodiol® or Custodiol-N to demonstrate noninferiority of Custodiol-N regarding both graft function and graft injury after transplantation. Preclinical data have clearly shown that Custodiol-N is superior to Custodiol® in cold static organ preservation via mechanisms including inhibition of hypoxic cell injury, cold-induced cell injury and avoidance of adverse effects during warm exposure to the solution. Further clinical safety data on Custodiol-N for cardioplegia are available. Thus, this study was designed to compare Custodiol® with Custodiol-N for the first time in a prospective, randomized, single-blinded, multicentre, phase III clinical transplantation trial. Eudra-CT, 2017-002198-20. Registered on 28 November 2018.
- Find related publications in this database (Keywords)
- Preservation solution
- Liver transplantation
- Kidney transplantation
- Pancreatic transplantation