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

NCT06530641 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-03-17

No results posted yet for this study

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.

Conditions

  • Cardiac Surgery
  • Cardioplegia
  • Heart Arrest

Interventions

DRUG

Custodiol Htk Soln

Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Custodiol crystalloid cardioplegia.

DRUG

Buckberg Cardi-Braun

Patients undergoing major cardiac surgery with extracorporeal circulation who are administered Buckberg blood cardioplegia.

Sponsors & Collaborators

  • Lourdes Montero Cruces

    lead OTHER

Principal Investigators

  • Lourdes Montero Cruces · Hospital San Carlos, Madrid

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06530641 on ClinicalTrials.gov