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Buckberg vs Del Nido in Isolated Aortic Valve Replacement

NCT04259515 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2025-06-22

No results posted yet for this study

Summary

The study compares safety and efficacy of the Del Nido cardioplegic solution, comparing it with the Buckberg cardioplegic solution in single aortic valve replacement procedures. Half the patients will receive the Del Nido solutions while the other half will receive the Buckberg solution.

Conditions

  • Cardiac Surgical Procedures

Interventions

DRUG

Del Nido

Del Nido cardioplegic solution administered in a single dose at 15-20mg/Kg with a maximum dose of 1L of solution, administered antegrade or retrograde. In those patients in wich the crossclamping time exceed 90 to 120 minutes a manteinance dose of 500ml will be administered.

DRUG

Buckberg

Buckberg cardioplegical solution administered antegrade and/or retrograde at 1-2ml/Kg for cardiac arrest induction. Arrest manteinance with antegrade and/or retrograde administration at 1-2ml/Kg every 15 to 20 minutes. Reperfusion dose with antegrade or retrograde administration at 15-20 ml/Kg before removing the aortic crossclamp.

Sponsors & Collaborators

  • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    lead OTHER

Principal Investigators

  • Manel Tauron, MD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-16
Primary Completion
2023-08-24
Completion
2023-08-24

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 NCT04259515 on ClinicalTrials.gov