Daniela Kniepeiss1,2, Philipp Houben3, Philipp Stiegler1,2, Andrea Berghold4, Regina Riedl4, Judith Kahn1,2, Peter Schemmer5,6. 1. General, Visceral and Transplant Surgery, Department of Surgery, Medical University of Graz, Auenbruggerplatz 29, 8036, Graz, Austria. 2. Transplant Center Graz (TCG), Medical University of Graz, Auenbruggerplatz 29, 8036, Graz, Austria. 3. Department of General, Visceral and Transplant Surgery, University Hospital of Heidelberg, Heidelberg, Germany. 4. Institute for Medical Informatics, Statistics and Documentation, Medical University Graz, Graz, Austria. 5. General, Visceral and Transplant Surgery, Department of Surgery, Medical University of Graz, Auenbruggerplatz 29, 8036, Graz, Austria. Peter.schemmer@medunigraz.at. 6. Transplant Center Graz (TCG), Medical University of Graz, Auenbruggerplatz 29, 8036, Graz, Austria. Peter.schemmer@medunigraz.at.
Abstract
BACKGROUND: 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. METHODS: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. DISCUSSION: 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. TRIAL REGISTRATION: Eudra-CT, 2017-002198-20. Registered on 28 November 2018.
RCT Entities:
BACKGROUND: 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. METHODS: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. DISCUSSION: 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. TRIAL REGISTRATION: Eudra-CT, 2017-002198-20. Registered on 28 November 2018.
Authors: Natsuki Eguchi; Kimia Damyar; Michael Alexander; Donald Dafoe; Jonathan R T Lakey; Hirohito Ichii Journal: Antioxidants (Basel) Date: 2022-05-24