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Custodiol-N versus Custodiol: results from a prospective noninferiority randomized single blind, multicenter phase 3 trial in patients undergoing heart transplantation

Background - Custodiol is a well-established preservation solution for organ transplantation and was the basis for the development of Custodiol-N to improve graft preservation. Previous results in coronary artery bypass graft surgery have shown effective cardiac protection without safety concerns. T...

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Hauptverfasser: Aliabadi-Zuckermann, Arezu Z. (VerfasserIn) , Osorio-Jaramillo, Emilio (VerfasserIn) , Knosalla, Christoph (VerfasserIn) , Gummert, Jan (VerfasserIn) , Szabó, Gábor (VerfasserIn) , Wittmann, Franziska (VerfasserIn) , Yeter, Ruhi (VerfasserIn) , Schramm, Rene (VerfasserIn) , Goekler, Johannes (VerfasserIn) , Hennig, Felix (VerfasserIn) , Morshuis, Michel (VerfasserIn) , Zuckermann, Andreas (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: August 2025
In: The journal of heart and lung transplantation
Year: 2025, Jahrgang: 44, Heft: 8, Pages: 1262-1272
ISSN:1557-3117
DOI:10.1016/j.healun.2025.03.021
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.healun.2025.03.021
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S1053249825018595
Volltext
Verfasserangaben:Arezu Aliabadi-Zuckermann, Emilio Osorio-Jaramillo, Christoph Knosalla, Jan Gummert, Gabor Szabo, Franziska Wittmann, Ruhi Yeter, Rene Schramm, Johannes Goekler, Felix Hennig, Michel Morshuis, and Andreas Zuckermann
Beschreibung
Zusammenfassung:Background - Custodiol is a well-established preservation solution for organ transplantation and was the basis for the development of Custodiol-N to improve graft preservation. Previous results in coronary artery bypass graft surgery have shown effective cardiac protection without safety concerns. This study aimed to evaluate the safety and ability of Custodiol-N to preserve cardiac grafts for heart transplantation. - Methods - This prospective, randomized, single-blind, multicenter, noninferiority study was conducted at three centers in Austria and Germany. The primary end-point was creatine kinase (CK-MB) peak value from 4 to 168 hours after opening of the aortic cross clamp, with a 30% noninferiority margin. Key secondary efficacy end-points include patient and graft survival, incidence of primary graft failure, or length of stay in the intensive care unit. The primary and secondary end-points were analyzed in both the treated and per protocol populations. - Results - A total of 105 randomized patients received Custodiol (n = 52) or Custodiol-N (n = 53) preserved hearts. Average donor age and ischemic times were comparable. Average CK-MB peak values were 176.94 ± 189.61 U/L for the Custodiol versus 130.51 ± 69.60 U/liter for the Custodiol-N group (p-value for noninferiority of Custodiol-N by 30% <0.0001). Patient survival was comparable 1-year post transplantation (90.4% for Custodiol versus 88.7% for Custodiol-N). The incidence of primary graft failure and median length of intensive care unit stay were higher for Custodiol group. Safety assessment showed evenly distributed adverse events. - Conclusions - This study shows that Custodiol-N is safe, noninferior, and provides similar cardiac graft protection as the established Custodiol solution.
Beschreibung:Online verfügbar: 23. April 2025, Artikelversion: 25. Juli 2025
Gesehen am 19.01.2026
Beschreibung:Online Resource
ISSN:1557-3117
DOI:10.1016/j.healun.2025.03.021

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