Comparing two types of cardioplegia in major heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase IV clinical trial is a single-blind, prospective, and longitudinal randomized intervention that compares the effects of Custodiol crystalloid cardioplegia and Buckberg blood cardioplegia in patients undergoing major cardiac surgery with extracorporeal circulation. The study aims to evaluate the non-inferiority of Custodiol cardioplegia, particularly in complex surgeries requiring longer aortic clamping times. By addressing the lack of standardized consensus on cardioplegia use, this trial seeks to provide clearer guidance on myocardial protection strategies during cardiac surgery. The trial will involve patients over 18 years of age with specific cardiac pathologies indicated for surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Clínico San Carlos
  Madrid, Madrid, Spain Recruiting

Study contacts

• Principal investigator: Lourdes Montero Cruces — Hospital San Carlos, Madrid
• Study coordinator: Lourdes Montero Cruces
• Email: lourdes.montero@salud.madrid.org
• Phone: 913303000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.