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)

Autor: Andrea Berghold, Regina Riedl, Daniela Kniepeiss, Judith Kahn, Philipp Houben, Peter Schemmer, Philipp Stiegler
Rok vydání: 2020
Předmět:
medicine.medical_specialty
Time Factors
medicine.medical_treatment
Organ Preservation Solutions
Medicine (miscellaneous)
Liver transplantation
Organ transplantation
Potassium Chloride
Kidney transplantation
Study Protocol
03 medical and health sciences
0302 clinical medicine
medicine
Humans
Multicenter Studies as Topic
Mannitol
Single-Blind Method
Pharmacology (medical)
Prospective Studies
Adverse effect
Randomized Controlled Trials as Topic
030304 developmental biology
lcsh:R5-920
0303 health sciences
Kidney
business.industry
Graft Survival
Pancreatic transplantation
Organ Preservation
medicine.disease
Preservation solution
Custodiol-N solution
Surgery
Transplantation
Glucose
Treatment Outcome
medicine.anatomical_structure
Clinical Trials
Phase III as Topic
Austria
030220 oncology & carcinogenesis
Tissue and Organ Harvesting
Pancreas Transplantation
lcsh:Medicine (General)
Pancreas
business
Procaine
Zdroj: Trials, Vol 21, Iss 1, Pp 1-13 (2020)
Trials
ISSN: 1745-6215
Popis: 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.
Databáze: OpenAIRE
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