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)
Phase 1
- Conditions
- congenital heart malformation inchildrenTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2024-511517-38-00
- Lead Sponsor
- Dr. Franz Koehler Chemie GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Age from birth to less than 18 years of age, congenital heart surgery with cardiopulmonary bypass and cardioplegia, written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study), Ability of the legal guardians to understand character and individual consequences of the clinical trial
Exclusion Criteria
Patients who have participated within 30 days or are still participating in any other interventional study, History of severe organic (e.g. liver or kidney) disease other than concerning the heart, History of psychiatric disease, Pregnancy and lactation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method