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)
| العنوان: | 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) |
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| المؤلفون: | Andrea Berghold, Regina Riedl, Daniela Kniepeiss, Judith Kahn, Philipp Houben, Peter Schemmer, Philipp Stiegler |
| المصدر: | Trials, Vol 21, Iss 1, Pp 1-13 (2020) Trials |
| بيانات النشر: | Springer Science and Business Media LLC, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | 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 |
| الوصف: | 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. |
| تدمد: | 1745-6215 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::cbc5c63f20c07211862d8b4b3dd416d2Test https://doi.org/10.1186/s13063-019-3823-4Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....cbc5c63f20c07211862d8b4b3dd416d2 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 17456215 |
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