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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)
EU CTIS ID: 2024-511517-38-00
What this study is testing
The main purpose of the clinical trial is safety assessment regarding Continuous adverse events (AEs) reporting up to 30 days postoperatively Myocardial protection in surviving patients, as assessed by quantification of perioperative CK-MB levels (U/l) until postoperative day 2 and postoperative day 7 or discharge
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.