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OpenTrials
Completed

NCT Number: NCT04259515

Buckberg vs Del Nido in Isolated Aortic Valve Replacement

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.

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Key information

Conditions

Cardiac Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients older than 18 years old
  • Patients listed for elective aortic valve replacement
  • Patients that have signed informed consent

Exclusion criteria

  • Emergent surgery
  • Patients that do not accept blood transfusion
  • Patients with previous cardiac surgery

Treatment and study plan

Del Nido

Drug

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.

Buckberg

Drug

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.

Primary outcomes

  1. Mortality

    Time frame: 30 days

    All cause mortality

  2. Troponin T

    Time frame: 5 days

    Troponin T blood levels

  3. CK

    Time frame: 5 days

    CK blood levels

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Randomized Multicentric Trial to Compare Efficacy and Security of Bucberg vs Del Nido Cardioplegic Solutions in Isolated Aortic Valve Replacement.

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 6, 2020
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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