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    Summary
    EudraCT Number:2019-000401-76
    Sponsor's Protocol Code Number:7715
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-03
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-000401-76
    A.3Full title of the trial
    Transfusion savings in heart surgery: impact of individual strategy, optimized by erythropoietin (EPO) and metabolic adjustment (ScvO2)
    Epargne transfusionnelle en chirurgie cardiaque : impact d’une stratégie individualisée, optimisée par Erythropoïétine (EPO) et ajustement métabolique (ScvO2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Transfusion savings in heart surgery
    Epargne transfusionnelle en chirurgie cardiaque
    A.3.2Name or abbreviated title of the trial where available
    BLOOCOST
    BLOOCOST
    A.4.1Sponsor's protocol code number7715
    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 SponsorUniversity hospital of Montpellier
    B.1.3.4CountryFrance
    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 supportUniversity hospital of Montpellier
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity hospital of Montpellier
    B.5.2Functional name of contact pointClaire CHAUVETON
    B.5.3 Address:
    B.5.3.1Street AddressDRI, Pav 32 - 39 avenue Charles Flahault
    B.5.3.2Town/ cityMontpellier
    B.5.3.3Post code34295
    B.5.3.4CountryFrance
    B.5.4Telephone number0033467330924
    B.5.5Fax number0033467339172
    B.5.6E-maildepotAC@chu-montpellier.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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 FERINJECT
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratory VIFOR FRANCE S.A.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFERRIC CARBOXYMALTOSE
    D.3.9.1CAS number 9007-72-1
    D.3.9.4EV Substance CodeSUB66620
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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.IMP: 2
    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 Venofer
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratory VIFOR FRANCE S.A.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIRON SUCROSE
    D.3.9.1CAS number 8047-67-4
    D.3.9.4EV Substance CodeSUB16439MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    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 Binocrit
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratory SANDOZ GmbH
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEPOETIN ALFA
    D.3.9.1CAS number 113427-24-0
    D.3.9.4EV Substance CodeSUB06575MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Heart failure
    Défaillance cardiaque
    E.1.1.1Medical condition in easily understood language
    Heart failure
    Défaillance cardiaque
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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 transfusional impact of a strategy optimized by EPO and ScvO2 versus standard management, in patients at risk of high transfusion in cardiac surgery.
    Evaluer l’impact transfusionnel d’une stratégie optimisée par EPO et ScvO2 versus une prise en charge standard, chez des patients à risque de transfusion élevé en chirurgie cardiaque.
    E.2.2Secondary objectives of the trial
    To evaluate the impact of optimized transfusion strategy on:
    - the incidence of intraoperative and postoperative transfusion (resuscitation and continuing care)
    - the number of transfused globular concentrates
    - the hemoglobin level at the hospital discharge
    - mortality, the duration of mechanical ventilation, the length of stay in intensive care and hospital
    - the incidence of postoperative complications: cardiac, renal, respiratory or infectious
    Evaluer l’impact de la stratégie transfusionnelle optimisée sur :
    - l’incidence de la transfusion en peropératoire et postopératoire (réanimation et soins continus)
    - le nombre de concentrés globulaires transfusés
    - le taux d’hémoglobine à la sortie d’hôpital
    - la mortalité, la durée de ventilation mécanique, les durées de séjour en réanimation et hospitalière
    - l’incidence des complications postopératoires : cardiaques, rénales, respiratoires ou infectieuses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patient adult> 18 years
    -Programmed heart surgery (> 24 hours)
    -High risk of perioperative transfusion: TRUST score ≥ 3 (Appendix 1) 20
    -Central venous catheter in superior vena territory controlled by chest X-ray
    -Patient affiliated or beneficiary of a social security scheme
    -Patient having signed the informed consent
    -Patient adulte > 18 ans
    -Chirurgie cardiaque programmée (> 24 heures)
    -Risque élevé de transfusion péri-opératoire : score de TRUST ≥ 3 (Annexe 1)20
    -Cathéter veineux central en territoire cave supérieur contrôlé par radiographie de thorax
    -Patient affilié ou bénéficiaire d’un régime de sécurité sociale
    -Patient ayant signé le consentement éclairé
    E.4Principal exclusion criteria
    - Contraindication to the use of EPO
    - Contraindication to the use of injectable iron
    - Persons unable to express their consent
    - Women ppregnant or breastfeeding
    - Patients already treated with EPO before inclusion
    -Contre indication à l’utilisation d’EPO
    -Contre indication à l’utilisation de fer injectable
    -Personnes hors d’état d’exprimer leur consentement
    -Femmes enceinte ou allaitante
    -Patients déjà traité par EPO avant inclusion
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of patients transfused during their hospital stay after cardiac surgery
    Incidence de patients transfusés au cours de leur séjour hospitalier après chirurgie cardiaque
    E.5.1.1Timepoint(s) of evaluation of this end point
    Maximum period of 28 days
    Période maximale de 28 jours
    E.5.2Secondary end point(s)
    1) Incidence of transfused patients intraoperatively and in intensive care / continuous care

    2) Number of RGCs transfused in intensive care unit and at day 28

    3) Total duration of mechanical ventilation at D28

    4) Length of stay in intensive care unit and hospital

    5) Incidence of mortality at day 28

    6) Incidence of postoperative complications occurring in intensive care and / or continuous care
    o Acute renal failure defined according to KDIGO criteria24
    o Cardiac complications: heart failure treated with inotropic (dobutamine) or temporary cardiac assistance type ECMO (Extracorporeal Membrane Oxygenation), incidence of arrhythmias (atrial fibrillation)
    o Vascular failure: treatment with norepinephrine outside a septic context
    o Respiratory failure: need for non-invasive ventilation, reintubation, prolonged mechanical ventilation for more than 12 hours
    o Neurological complications: ischemic vascular accident, defined by clinical and radiological signs
    o Mesenteric ischemia authenticated by colonoscope or surgery
    o Hepatic failure (elevation 2N biological markers)
    o Septic complications: sepsis or septic shock according to the international consensus25
    1) Incidence de patients transfusés en peropératoire et en réanimation/soins continus

    2) Nombre de CGR transfusés en réanimation et à J28

    3) Durée totale de ventilation mécanique à J28

    4) Durée de séjour en réanimation et à l’hôpital

    5) Incidence de la mortalité à J28

    6) Incidence des complications postopératoires survenant en réanimation et/ou soins continus
    o Insuffisance rénale aigüe définie selon les critères KDIGO24
    o Complications cardiaques : insuffisance cardiaque traitée par inotrope (dobutamine) ou nécessité d’assistance cardiaque temporaire type ECMO (Extracorporeal Membrane Oxygenation), incidence de troubles du rythme (fibrillation auriculaire)
    o Défaillance vasculaire : traitement par noradrénaline en dehors d’un contexte septique
    o Défaillance respiratoire : nécessité d’une ventilation non invasive, d’une réintubation, d’une ventilation mécanique prolongée de plus de 12 heures
    o Complications neurologiques : accident ischémique vasculaire, défini par les signes cliniques et radiologiques
    o Ischémie mésentérique authentifiée par coloscope ou chirurgie
    o Défaillance hépatique (élévation marqueurs biologiques 2N)
    o Complications septiques : sepsis ou choc septique selon le consensus international25
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) During surgery and in intensive care / continuous care
    2) In intensive care and at day 28
    3) At J28
    5) At J28
    6) During resuscitation / continuing care
    1) Pendant la chirurgie et en réanimation/soins continus
    2) En réanimation et à J28
    3) A J28
    5) A J28
    6) Pendant la réanimation /soins continus
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Comparison of two transfusion strategies
    Comparaison de deux stratégies transfusionnelles
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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
    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 months
    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.1.3Elderly (>=65 years) Yes
    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 state128
    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
    Prise en charge habituelle
    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 Decision2019-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-26
    P. End of Trial
    P.End of Trial StatusOngoing
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