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    Summary
    EudraCT Number:2018-002701-59
    Sponsor's Protocol Code Number:IIBSP-CAR-2018-71
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-17
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-002701-59
    A.3Full title of the trial
    Randomized, open and multi-center clinical trial to compare the efficacy and safety of Buckberg vs Del Nido cardioplegia in isolated aortic valve replacement
    Ensayo clínico aleatorizado, abierto y multicéntrico para comparar la eficacia y seguridad de la cardioplegia Buckberg vs Del Nido en sustitución valvular aórtica aislada
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to compare Buckberg cardioplegia and Del Nido cardioplegia in isolated aortic valve replacement surgery
    Estudio para comparar la cardioplegia de Buckberg y la cardioplegia Del Nido en cirugía de sustitución valvular aórtica aislada
    A.4.1Sponsor's protocol code numberIIBSP-CAR-2018-71
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstitut de Recerca Hospital de la Santa Creu i Sant Pau
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInstitut de Recerca Hospital de la Santa Creu i Sant Pau
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca Hospital de la Santa Creu i Sant Pau
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street AddressSant Quintí 77-79
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.3.4CountrySpain
    B.5.4Telephone number+34935537636
    B.5.5Fax number+34935537812
    B.5.6E-mailepenag@santpau.cat
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cardi-Braun
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Medical, SA
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracoronary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTROMETAMOL CITRATE
    D.3.9.3Other descriptive nameTROMETAMOL CITRATE
    D.3.9.4EV Substance CodeSUB04993MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8.7560
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM CITRATE
    D.3.9.3Other descriptive nameSODIUM CITRATE
    D.3.9.4EV Substance CodeSUB12582MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5840
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCITRIC ACID MONOHYDRATE
    D.3.9.3Other descriptive nameCITRIC ACID MONOHYDRATE
    D.3.9.4EV Substance CodeSUB76183
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1976
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOTASSIUM CHLORIDE
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.7960
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM CHLORIDE
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number9.8600
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLUCOSE MONOHYDRATE
    D.3.9.3Other descriptive nameGLUCOSE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB13983MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number34.66
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Myocardial protection
    Protección miocárdica
    E.1.1.1Medical condition in easily understood language
    Heart protection
    Protección del corazón
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy and safety of myocardial protection with a cardioplegic solution of the Nido, compared to the Buckberg cardioplegic solution in patients undergoing isolated aortic valve replacement. This efficacy on myocardial protection will be measured by comparing the levels of markers of myocardial injury (CK and Troponin T) between both strategies, as well as in-hospital mortality.
    Evaluar la eficacia y seguridad de la protección miocárdica con solución cardioplégica Del Nido, frente a la solución cardioplégica Buckberg en pacientes intervenidos de sustitución valvular aórtica aislada. Dicha eficacia sobre la protección miocárdica se medirá comparando los niveles de marcadores de lesión miocárdica (CK y Troponina T) entre ambas estrategias, así como mortalidad hospitalaria.
    E.2.2Secondary objectives of the trial
    To compare other markers of myocardial injury such as LVEF by transthoracic echocardiography, postoperative inotropic need, spontaneous recovery of the post-disinfestation cardiac rhythm or the need for defibrillation.

    To compare other markers of hemodilution (minimum intraoperative and postoperative hemoglobin and need for transfusion), intra and postoperative glucose and insulin needs, other intraoperative analytical parameters such as intraoperative maximum lactate, aortic clamping times and CPB between both types of cardioplegia.
    Comparar otros marcadores de lesión miocárdica como FEVI por ecocardiografia transtorácica, necesidad de inotrópicos postoperatorios, recuperación espontanea del ritmo cardiaco post-despinzamiento o necesidad de desfibrilación.

    Comparar otros parámetros marcadores de hemodilución (hemoglobina mínima intraoperatoria y postoperatoria y necesidad de transfusión), glucosa intra y postoperatoria y necesidades de insulina, otros parámetros analíticos intraoperatorios como lactato máximo intraoperatorio, tiempos de pinzamiento aórtico y CEC entre ambos tipos de cardioplegia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients of legal age (> 18 years) of both sexes

    Patients who were electively operated on isolated aortic valve replacement in any of the three participating centers.

    Patients who give informed consent
    Pacientes mayores de edad (>18 años) de ambos sexos

    Pacientes intervenidos electivamente de sustitución valvular aórtica aislada en cualquiera de los tres centros participantes.

    Pacientes que otorguen el consentimiento informado
    E.4Principal exclusion criteria
    Urgent or emergent surgery

    Patients who refuse transfusion of blood products

    Patients who do not accept to participate
    Cirugía urgente o emergente

    Pacientes que rechacen transfusión de hemoderivados

    Pacientes que no acepten participar
    E.5 End points
    E.5.1Primary end point(s)
    Peak levels of CK in U / L and ultrasensitive Troponin T in ng / L in blood during the postoperative period: the levels of CK and Troponin T in blood will be determined in the first 24 hours postoperatively and later on a daily basis until the peak of both parameters is determined (usually occurs between 2 and 4 days postoperatively). The peak of CK and Troponin T of each of the study subjects will be recorded.

    Operative mortality: Operative mortality will be considered, mortality within 30 days after surgery, or mortality during admission of the intervention (in patients whose hospital stay exceeds 30 days postoperatively).
    Niveles pico de CK en U/L y Troponina T ultrasensible en ng/L en sangre durante el postoperatorio: se determinarán los niveles de CK y Troponina T en sangre las primeras 24 horas postoperatorias y posteriormente de manera diaria hasta determinar el pico de ambos parámetros (usualmente se produce entre 2 y 4 días postoperatorios). Se registrará el pico de CK y de Troponina T de cada uno de los sujetos de estudio.

    Mortalidad operatoria. Se considerará mortalidad operatoria, la mortalidad en los siguientes 30 días a la intervención quirúrgica, o la mortalidad durante el ingreso de la intervención (en pacientes en que el ingreso supere los 30 días postoperatorios).
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 - 4 days and 30 days for each primary endpoint respectively
    1 - 4 días y 30 días para cada variable primaria respectivamente
    E.5.2Secondary end point(s)
    Spontaneous recovery of aortic post-release rhythm: it will be recorded during the intraoperative period if there is spontaneous recovery of the heart rhythm when removing the aortic clamp.
    Need for post-aortic defibrillation: it will be recorded if defibrillation is necessary or not when removing the aortic clamp.
    Need for inotropes for CEC disconnection: the administration of inotropes for the CEC disconnection will be recorded if necessary or not. If yes, it will also be recorded what inotropes are necessary and in what dose.
    Minimum intraoperative hemoglobin (in g / L)
    Need for transfusion of red blood cells
    Maximum intraoperative glycemia (in mmol / L)
    Intraoperative insulin needs
    Insulin needs in the first 48 hours after surgery
    Maximum intraoperative lactate (in mmol / L)
    Aortic Impingement Time (minutes)
    Extracorporeal circulation time (minutes)
    Left ventricular function by echocardiography at discharge
    Left ventricular function by echocardiography at 3-6 months postoperatively
    Recuperación espontánea del ritmo post-despinzamiento aórtico: se registrará durante el periodo intraoperatorio si existe recuperación espontánea del ritmo cardiaco al retirar la pinza aórtica.
    Necesidad de desfibrilación post-despinzamiento aórtico: se registrará si es necesaria desfibrilación o no al retirar la pinza aórtica.
    Necesidad de inotrópicos para desconexión de CEC: se registrará si es necesario o no la administración de inotrópicos para la desconexión de CEC. En caso afirmativo, se registrará también qué inotrópicos son necesarios y en qué dosis.
    Hemoglobina mínima intraoperatoria (en g/L)
    Necesidad de transfusión de hematíes
    Glucemia máxima intraoperatoria (en mmol/L)
    Necesidades de insulina intraoperatoria
    Necesidades de insulina en las primeras 48 horas postoperatorias
    Lactato máximo intraoperatorio (en mmol/L)
    Tiempo de pinzamiento aórtico (minutos)
    Tiempo de circulación extracorpórea (minutos)
    Función ventricular izquierda por ecocardiografia al alta
    Función ventricular izquierda por ecocardiografia a los 3-6 meses postoperatorios
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 hours, 3 months and 6 months
    24 horas, 3 meses y 6 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 398
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state388
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-27
    P. End of Trial
    P.End of Trial StatusOngoing
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