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: | , , , , , , , , , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
August 2025
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| 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 
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| 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 |
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| 245 | 1 | 0 | |a Custodiol-N versus Custodiol |b results from a prospective noninferiority randomized single blind, multicenter phase 3 trial in patients undergoing heart transplantation |c 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 |
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| 520 | |a 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. | ||
| 650 | 4 | |a heart transplantation | |
| 650 | 4 | |a HTK | |
| 650 | 4 | |a HTK-N | |
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| 700 | 1 | |a Knosalla, Christoph |e VerfasserIn |4 aut | |
| 700 | 1 | |a Gummert, Jan |e VerfasserIn |4 aut | |
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| 700 | 1 | |a Morshuis, Michel |e VerfasserIn |4 aut | |
| 700 | 1 | |a Zuckermann, Andreas |e VerfasserIn |4 aut | |
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