CUSTODIOL® - Perfusionslösung

DRUG4 trials

Sponsors

Dr. Franz Koehler Chemie GmbH, Hospital Clinico San Carlos

Conditions

Cardiovascular surgerycongenital heart malformation inchildrenheart transplantation in childrenliver or kidney-pancreatic transplantationpatients who will undergo kidney

Phase 2

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

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

Phase 4

Evaluation of clinical impact of the type of cardioplegia used in the patient undergoing major cardiac surgery with extracorporeal circulation. CARDIO-HEART clinical trial.

Not yet recruitingCTIS2024-511948-42-00

Hospital Clinico San CarlosCardiovascular surgery

Target: 600Updated: 2024-06-03