Clinical Trial

Study of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children

Suspended Phase 2
View on ClinicalTrials.gov →
Why the trial stopped
Sponsor Decision
Summary
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)
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-26.
Trial Details
NCT Number NCT07381530
Lead Sponsor Dr. F. Köhler Chemie GmbH
Conditions Congenital Heart Malformations
Enrollment 100 participants
Start Date 2024-12-05
Primary Completion 2026-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-09