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Custodiol-N

DRUG8 trials

Sponsors

Dr. Franz Koehler Chemie GmbH, Dr. F. Köhler Chemie GmbH

Conditions

Aortic Valve DiseaseCoronary Artery Disease (CAD)Heart FailureHeart TransplantationLiver transplantationcongenital heart malformation inchildrenheart transplantation in childrenliver or kidney-pancreatic transplantation

Phase 2

Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery
CompletedNCT01444235
Dr. F. Köhler Chemie GmbHCoronary Artery Disease (CAD)
Start: 2011-03-31End: 2012-07-31Updated: 2013-05-17
Study of Organ Perfusion in Heart Transplantation in Children
RecruitingNCT06032195
Dr. F. Köhler Chemie GmbHHeart Transplantation
Start: 2023-08-15End: 2027-09-01Target: 15Updated: 2026-01-30
A prospective randomized single blind multicenter phase II study of organ perfusion with Custodiol-N compared with Custodiol in heart transplantation in children (CL-N-HTX-Paed-II/10/20)
RecruitingCTIS2023-510492-57-00
Dr. Franz Koehler Chemie GmbHheart transplantation in children
Start: 2025-03-05Target: 15Updated: 2025-12-04
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 (CL-N-CP-Paed-II/09/19)
SuspendedCTIS2024-511517-38-00
Dr. Franz Koehler Chemie GmbHcongenital heart malformation inchildren
Start: 2024-11-05Target: 100Updated: 2025-03-28

Phase 3

Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
CompletedNCT02098772
Dr. F. Köhler Chemie GmbHAortic Valve Disease, Coronary Artery Disease (CAD)
Start: 2014-05-31End: 2018-12-31Updated: 2020-01-18
Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation
CompletedNCT02869022
Dr. F. Köhler Chemie GmbHHeart Failure
Start: 2016-07-31End: 2019-09-02Updated: 2020-01-18
A prospective, randomized, single blind, multicentre phase III study on organ preservation with Custodiol-N solution compared with Custodiol solution in or-gan transplantation (kidney, liver and pancreas)
RecruitingCTIS2024-512444-29-00
Dr. Franz Koehler Chemie GmbHliver or kidney-pancreatic transplantation, patients who will undergo kidney
Start: 2019-05-07Target: 362Updated: 2025-12-09
A Prospective, randomized, single blind, multicenter Phase III study on organ preservation with Custodiol-N solution compared with Custodiol solution in liver transplantation
Not yet recruitingCTIS2024-518174-13-00
Dr. Franz Koehler Chemie GmbHLiver transplantation
Target: 200Updated: 2025-12-22