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Recruiting Phase 4 NCT06530641

Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery.

Trial Parameters

Condition Cardiac Surgery
Sponsor Lourdes Montero Cruces
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 600
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-12-01
Completion 2026-11
Interventions
Custodiol Htk SolnBuckberg Cardi-Braun

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.

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