Sponsor Decision
A Prospective Randomized, Single-blind, Multicenter Phase II Study Comparing Two Methods of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children: Custodiol-N Versus Custodiol
Sponsor study identifier
interventional
100
1 country
3
Study Start
December 5, 2024
Actual (reported)Primary Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The objective of this investigation is to compare the safety and cardioprotective effects of Custodiol and Custodiol-N in children undergoing cardiac surgery with cardiopulmonary bypass (CPB) due to congenital heart malformation. All endpoint timings refer to the opening of the aortic cross clamp (t=0)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 28, 2024
Actual (reported)December 5, 2024
Actual (reported)February 2, 2026
Actual (reported)December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
safety assessment
Continuous adverse events (AEs) reporting
AEs up to 30 days postoperatively
safety assessment
Myocardial protection in surviving patients assessed by quantification of perioperative CK-MB levels (U/l)
CK-MB (Creatinkinase-MB) levels at baseline until postoperative day 2 and postoperative day 7 or discharge
Description of hemodynamics
day 7 postoperatively
Description of hemodynamics
day 7 postoperatively
Description of hemodynamics
day 7 postoperatively
Description of hemodynamics
day 7 postoperatively
Description of hemodynamics
day 7 postoperatively
organ will be perfused with Custodiol-N solution
organ will be perfused with Custodiol solution
cardioplegia solution will be administered with perfusion
cardioplegia solution will be administered with perfusion
Universitätsklinikum Gießen und Marburg GmbH, Abteilung für Kinderherzchirurgie und angeborene Herzfehler
Giessen, 35385, Germany
Deutsches Herzzentrum München, TUM Universitätsklinikum, Klinik für Chirurgie angeborener Herzfehler und Kinderherzchirurgie
München, 80636, Germany
Universitätsklinikum Münster, Klinik für Herz- und Thoraxchirurgie,Sektion Kinderherzchirurgie
Münster, 48149, Germany
Philippe Grieshaber, PD Dr.
Sektion Kinderherzchirurgie, Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Münster, Germany
Christine-Elena Kamla, Dr.
Deutsches Herzzentrum München, TUM Universitätsklinikum, Germany
Mohamed Salem, Dr.
Kinderherzzentrum, Universitätsklinikum Gießen und Marburg GmbH, Germany
First Submitted
October 28, 2024
First Posted
February 2, 2026
Study Start
December 5, 2024
Actual (reported)Primary Completion
December 2026
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 9, 2026
Record last verified: 2026-02
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Source: ClinicalTrials.gov.
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