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)
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.
Publication type: | Randomised Controlled Trial |
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Organ: | Kidney; Pancreas; Liver; Various |
Language: | Engish |
MeSH terms: | Austria; Clinical Trials, Phase III as Topic; Glucose; Graft Survival; Humans; Kidney Transplantation; Liver Transplantation; Mannitol; Multicenter Studies as Topic; Organ Preservation; Organ Preservation Solutions; Pancreas Transplantation; Potassium Chloride; Procaine; Prospective Studies; Randomized Controlled Trials as Topic; Single-Blind Method; Time Factors; Tissue and Organ Harvesting; Treatment Outcome; 0 (Bretschneider Cardioplegic Solution); 0 (Custodiol-N Solution); 0 (Organ Preservation Solutions); 3OWL53L36A (Mannitol); 4Z8Y51M438 (Procaine); 660YQ98I10 (Potassium Chloride); IY9XDZ35W2 (Glucose) |