NCT06530641 Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.
| NCT ID | NCT06530641 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Lourdes Montero Cruces |
| Condition | Cardiac Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 600 participants |
| Start Date | 2024-12-01 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 600 participants in total. It began in 2024-12-01 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Phase IV clinical trial of a single-blind, prospective and longitudinal randomized intervention comparing patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia versus Buckberg blood cardioplegia.
Eligibility Criteria
Inclusion Criteria: * Patients over 18 years of age. * Patients with cardiac pathology and indication for major cardiac surgery with extracorporeal circulation and aortic clamping. Exclusion Criteria: 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.
Contact & Investigator
Lourdes Montero Cruces
PRINCIPAL INVESTIGATOR
Hospital San Carlos, Madrid
Frequently Asked Questions
Who can join the NCT06530641 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06530641 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06530641 currently recruiting?
Yes, NCT06530641 is actively recruiting participants. Contact the research team at lourdes.montero@salud.madrid.org for enrollment information.
Where is the NCT06530641 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06530641 clinical trial?
NCT06530641 is sponsored by Lourdes Montero Cruces. The principal investigator is Lourdes Montero Cruces at Hospital San Carlos, Madrid. The trial plans to enroll 600 participants.