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Search / Trial NCT06530641

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

Launched by LOURDES MONTERO CRUCES · Jul 26, 2024

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of different types of cardioplegia, which is a solution used to protect the heart during major cardiac surgery when the heart is temporarily stopped. The trial is comparing two specific methods: one using a special crystalloid solution called Custodiol and the other using blood known as Buckberg. Researchers want to see which method has a better impact on patients during and after their surgery.

To be eligible for this study, participants should be adults over 18 years old who are scheduled for major heart surgery that requires stopping the heart and using a heart-lung machine. However, some people may not qualify, including those who are pregnant or have certain heart conditions. If you join the study, you will be randomly assigned to receive one of the two cardioplegia methods. The trial is currently seeking participants, and it aims to gather valuable information that could help improve heart surgery care in the future.

Gender

ALL

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.

About Lourdes Montero Cruces

Lourdes Montero Cruces is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With expertise in managing and overseeing clinical trials across various therapeutic areas, the organization prioritizes adherence to regulatory standards and ethical practices. Lourdes Montero Cruces collaborates with healthcare professionals and research institutions to facilitate innovative studies that aim to develop new therapies and enhance existing treatments. Their focus on rigorous data collection and analysis ensures the integrity of research findings, ultimately contributing to the advancement of healthcare knowledge and patient care.

Locations

Madrid, , Spain

Patients applied

0 patients applied

Trial Officials

Lourdes Montero Cruces

Principal Investigator

Hospital San Carlos, Madrid

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported