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Evaluation of clinical impact of the type of cardioplegia used in the patient undergoing major cardiac surgery with extracorporeal circulation. CARDIO-HEART clinical trial.
EU CTIS ID: 2024-511948-42-00
What this study is testing
General objective: The objective of the present study is to demonstrate the non-inferiority of Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia in patients undergoing major cardiac surgery with extracorporeal circulation with prolonged aortic clamping times.
- Therapeutic use (Phase IV)
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
- Patients over 18 years of age.
- Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.
You likely can't join if
- 1. Pregnancy.
- 2. Aortic arch procedures.
- 3. Procedures in which hypothermia <28ºC is expected during the intervention.
- 4. Minimally invasive procedures “Port Access”.
- 5. Active endocarditis.
- 6. Emerging procedures.
See the full eligibility criteria
- Patients over 18 years of age.
- Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping.
- 1. Pregnancy.
- 2. Aortic arch procedures.
- 3. Procedures in which hypothermia <28ºC is expected during the intervention.
- 4. Minimally invasive procedures “Port Access”.
- 5. Active endocarditis.
- 6. Emerging procedures.
- 7. Isolated aortic valve replacements.
- 8. Decision of the main surgeon not to participate in the study due to other clinical criteria.
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, 18-64 years, 65+ 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.