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    Summary
    EudraCT Number:2016-002162-30
    Sponsor's Protocol Code Number:HC-G-H-1504
    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:2018-11-29
    Trial results View 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 number2016-002162-30
    A.3Full title of the trial
    Prospective, randomized, controlled, double-blind, multicentre, multinational study on the safety and efficacy of 6% Hydroxyethyl starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery
    Étude prospective, randomisée, contrôlée, en double aveugle, multicentrique, internationale, visant à évaluer la sécurité et l’efficacité d’une solution d’hydroxyéthylamidon (HEA) à 6 % par comparaison avec une solution électrolytique chez des patients bénéficiant d’une chirurgie abdominale non urgente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Controlled, international study conducted in several centres on the safety and therapeutic effect of a Hydroxylethyl-starch (HES) solution versus an electrolyte solution in patients undergoing elective abdominal surgery
    A.3.2Name or abbreviated title of the trial where available
    PHOENICS
    A.4.1Sponsor's protocol code numberHC-G-H-1504
    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 SponsorB. Braun Melsungen AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportB. Braun Melsungen AG
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportFresenius Kabi Deutschland GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationB. Braun Melsungen AG
    B.5.2Functional name of contact pointTamara Dehnhardt
    B.5.3 Address:
    B.5.3.1Street AddressCarl-Braun-Strasse 1
    B.5.3.2Town/ cityMelsungen
    B.5.3.3Post code34212
    B.5.3.4CountryGermany
    B.5.4Telephone number00495661712290
    B.5.5Fax number00495661752290
    B.5.6E-mailtamara.dehnhardt@bbraun.com
    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 Volulyte 6%, solution pour perfusion
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi France S.A.S.
    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 INNPoly(O-2-hydroxyethyl)starch
    D.3.9.1CAS number 9005-27-0
    D.3.9.3Other descriptive nameHydroxyethyl starch 130/0.4
    D.3.9.4EV Substance CodeSUB90155
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60.00
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.02
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPotassium chloride
    D.3.9.1CAS number 7447-40-7
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagensium chloride hexahydrate
    D.3.9.1CAS number 7791-18-6
    D.3.9.3Other descriptive nameMAGNESIUM CHLORIDE HEXAHYDRATE
    D.3.9.4EV Substance CodeSUB12526MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium acetate trihydrate
    D.3.9.1CAS number 6131-90-4
    D.3.9.3Other descriptive nameSODIUM ACETATE TRIHYDRATE
    D.3.9.4EV Substance CodeSUB15266MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.63
    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 IONOVEN, solution pour perfusion
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi France S.A.S.
    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 INNSodium chloride
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.02
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPotassium chloride
    D.3.9.1CAS number 7447-40-7
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMagnesium chloride hexahydrate
    D.3.9.1CAS number 7791-18-6
    D.3.9.3Other descriptive nameMAGNESIUM CHLORIDE HEXAHYDRATE
    D.3.9.4EV Substance CodeSUB12526MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium acetate trihydrate
    D.3.9.1CAS number 61341-90-4
    D.3.9.3Other descriptive nameSODIUM ACETATE TRIHYDRATE
    D.3.9.4EV Substance CodeSUB15266MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.63
    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
    Hypovolaemia due to acute blood loss in elective abdominal surgery
    Hypovolémie due à une perte sanguine aiguë dans le cadre d’une chirurgie abdominale non urgente
    E.1.1.1Medical condition in easily understood language
    Decreased blood volume due to acute blood loss during scheduled surgery of the abdomen
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021137
    E.1.2Term Hypovolaemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigate the safety and efficacy of a 6% HES 130 versus an electrolyte solution in patients undergoing elective abdominal surgery
    Évaluer la sécurité d’une solution d’HEA 130 à 6 % par comparaison avec une solution électrolytique chez des patients bénéficiant d’une chirurgie abdominale non urgente
    E.2.2Secondary objectives of the trial
    Further investigation of safety and efficacy of the applied products
    Évaluations supplémentaires de la sécurité et de l’efficacité des produits de l’étude administrés
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female adult patients > 40 and ≤ 85 years of age
    Women of childbearing potential must test negative on standard pregnancy test (urine or serum)
    Patients undergoing elective abdominal surgery with an expected blood loss of ≥ 500 ml
    ASA Physical Status II-III
    Signed written consent form
    Patients adultes, de sexe masculin ou féminin, âgés de > 40 ans et ≤ 85 ans
    Les femmes en âge de procréer doivent obtenir un résultat négatif à un test de grossesse standard (urinaire ou sanguin)
    Patients bénéficiant d’une chirurgie abdominale non urgente associée à une perte sanguine anticipée de ≥ 500 mL
    Score ASA (état physique) de II – III
    Formulaire de consentement éclairé signé
    E.4Principal exclusion criteria
    Hypersensitivity to the active substances or to any of the other excipients of the investigational products
    Body weight ≥ 140 kg
    Sepsis
    Burns
    Renal impairment (AKIN stage ≥ 1 or chronic) or acute and/or chronic renal replacement therapy
    Intracranial or cerebral haemorrhage
    Critically ill patients (typically admitted to the intensive care unit)
    Dehydration
    Hyperhydration
    Pulmonary oedema
    Congestive heart failure
    Severe hypernatraemia,
    Severe hyperchloraemia
    Hyperkalaemia
    Metabolic alkalosis
    Severely impaired hepatic function
    Severe coagulopathy
    Organ transplant patients
    Simultaneous participation in another interventional trial (drugs or medical device)
    Hypersensibilité aux substances actives ou à l’un des excipients contenus dans les médicaments de l’étude
    Masse corporelle ≥ 140 kg
    Sepsis
    Brûlures
    Insuffisance rénale (stade AKIN ≥ 1 ou chronique), ou traitement de substitution rénale aigu et/ou chronique
    Hémorragie intracrânienne ou cérébrale
    Patients en état critique (habituellement admis en unité de soins intensifs)
    Hyperhydratation
    OEdème pulmonaire
    Déshydratation
    Hyperkaliémie
    Hypernatrémie sévère
    Hyperchlorémie sévère
    Insuffisance hépatique sévère
    Insuffisance cardiaque congestive
    Coagulopathie sévère
    Greffe d’organe
    Alcalose métabolique
    Participation simultanée à un autre essai clinique interventionnel (étude de médicaments ou de dispositifs médicaux)
    E.5 End points
    E.5.1Primary end point(s)
    Difference in mean estimated glomerular filtration rate (eGFR) between the two treatment groups, calculated from the highest Cystatin-C level measured during post-operative days (POD) 1-3.
    Différence entre les deux groupes de traitement au niveau du débit de filtration glomérulaire estimé (DFGe) (calculé d’après les taux maximaux de cystatine C mesurés au cours des jours postopératoires (JPO) 1-3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Cystatin-C levels will be determined on POD 1-3. eGFR will be calculated from the highest Cystain-C level during this period.
    E.5.2Secondary end point(s)
    Safety
    - Renal function: Cystatin-C, serum creatinine (SCr), Cystatin-C based estimated glomerular filtration rate (eGFR), Cystatin-C based mean eGFR, SCr based eGFR, AKIN & RIFLE score (calculated), unrine output (if available)
    - Coagulation: Platelet count, International norm ration (INR), activated partial thromboplastin time (aPTT)
    - Inflammation: C-reactive protein (C-RP)
    - Adverse events: (serious) adverse events ((S)AEs / reactions ((S)ARs)
    - Calculated red blood cell (RBC) loss
    - Estimated intra-operative blood loss
    - Outcome: Length of stay (LOS) in the hospital (LOS-H), LOS in the intensive care unit (LOS-ICU; if applicable), fit for discharge from ICU / hospital, hours on mechanical ventilation (MV), mortality (in hospital/out of hospital) and its cause, days on RRT, (new) renal replacement therapy (RRT)

    Efficacy
    - Fluid administration: administration of IP volume
    - Fluid balance: fluid input and output
    - Haemodynamics / vital signs: temperature (T), heart rate (HR), mean arterial pressure (MAP), systolic arterial blood pressure (SAP), diastolic arterial blood pressure (DAP), central venous pressure (CVP, if available)
    - At least one of the following parameters to evaluate responsiveness and guide administration (vol guide): stroke volume (SV), stroke volume variation (SVV), stroke volume index (SVI), pulse pressure variation (PPV)
    Arterial (preferred) Blood Gas Analysis (ABGA): partial pressure of carbondioxide (pCO2), partial pressure of oxygen (pO2), hydrogen carbonate (HCO3-), arterial oxygen saturation (SaO2), haemoglobin (Hb), haematocrit (Hct), pH, base excess (BE), lactate
    centralvenous oxygen saturation (ScvO2)
    Serum electrolytes (S elyte): Sodium, potassium, calcium, chloride
    Major post-operative complications

    Definition of time-points
    Screening (within 1 week before surgery)
    T0 (Baseline; after randomization and prior to induction of anaesthesia)
    T1 (during surgery)
    T2 (end of surgery)
    T3 (POD 1 morning)
    T4 (POD 2-3 morning)
    T5 (POD 4-7 morning morning or hospital discharge, whatever occurs first)
    T6 (POD 8-10 morning or hospital discharge, whatever occurs first)
    T7 ( POD 28) ± 5 days
    T8 (POD 90) ± 14 days
    T9 (1 year PO) ± 30 days
    Sécurité
    - Fonction rénale: Cystatine C, Dosage sérique de la créatinine (SCr), Débit de filtration glomérulaire estimé (DFGe) sur la base de la cystatine C, DFGe moyen sur la base de la cystatine C, DFGe calculé sur la base de la SCr, Score AKIN & RIFLE (calculé), Débit urinaire (si disponible)
    - Coagulation: Numération plaquettaire, Ratio international normalisé (INR), Temps de céphaline activé (TCA)
    - Inflammation Protéine C réactive (PCr)
    - Événements indésirables: Événements / réactions indésirables (graves) (EI[G] / RI[G])
    - Perte de globules rouges (GR) calculée
    - Perte sanguine peropératoire estimée
    - Issue: Durée de séjour (DDS) à l’hôpital (DDS-H), DDS en unité de soins intensifs (USI) (DDS-USI; le cas échéant), Déclaré apte à quitter l’USI/l’hôpital, Heures passées sous ventilation artificielle (VA), Mortalité (intra-hospitalière / extra-hospitalière) en précisant la cause, jours d’un TSR, (Nouveau) traitement de substitution rénale (TSR)

    Efficacité
    - Administration de liquide: Volume de produit de l’étude administré
    - Équilibre hydrique: Apport et élimination hydrique
    - Paramètres hémodynamiques / signes vitaux: Température (T), Fréquence cardiaque (FC), Pression artérielle moyenne (PAM), Pression artérielle systolique (PAS), Pression artérielle diastolique (PAD), Pression veineuse centrale (PVC) (si disponible)
    - au moins l’un des paramètres suivants pour évaluer la réponse à l’expansion volémique et guider l’administration du produit de l’étude suivant l’algorithme volémique (vol guide) : Volume systolique (VS), Variation du volume systolique (VVS), Volume systolique indexé (VSI), Variation de la pression pulsée (VPP), Pression artérielle moyenne (PAM)
    Analyse des gaz du sang (GDS) artériel (de préférence): Pression partielle du gaz carbonique (PCO2), Pression partielle de l’oxygène du sang (PO2), Bicarbonate (HCO3-), Saturation artérielle en oxygène (SaO2), Taux d’hémoglobine (Hb), Hématocrite (Ht), pH, Excès de bases, Lactate
    Saturation veineuse centrale en oxygène (SvcO2)
    Électrolytes sériques (ES): Sodium, Potassium, Calcium, Chlorure
    Complications postopératoires majeures (CPM)

    Sélection (dans un délai de 1 semaine avant la chirurgie)
    T0 (Inclusion; après la randomisation et avant l’induction de l’anesthésie)
    T1 (pendant la chirurgie)
    T2 (fin de l’intervention chirurgicale)
    T3 (1re matinée postopératoire)
    T4 (2e & 3e matinées postopératoires)
    T5 (de la 4e à la 7e matinée postopératoire, ou à la sortie d’hôpital, selon ce qui se produit en premier)
    T6 (de la 8e à la 10e matinée postopératoire, ou à la sortie d’hôpital, selon ce qui se produit en premier
    T7 (jour 28 après la chirurgie) ± 5 jours
    T8 (jour 90 après la chirurgie) ± 14 jours
    T9 (1 an après la chirurgie) ± 30 jours

    E.5.2.1Timepoint(s) of evaluation of this end point
    Cystatin-C: T0, T2-T8
    SCr: T0, T2, T3, T4, T7, T8
    Cystatin-C-based eGFR: T0, T2, T3, T4, T7, T8
    Cystatin-C-based mean eGFR: T3-T6
    SCr-based eGFR: T0, T2, T3, T4, T7, T8
    AKIN and RIFLE: T0, T2, T3, T4, T7, T8
    Urin output: T0, T2-T4
    Coagulation: T0, T2, T3
    C-RP: T0, T2, T3
    (S)AEs/(S)ARs: T0-T8
    Blood loss - RBC:T4 & intra-op: T2
    LOS-H, LOS-ICU, Fit for discharge - H & ICU: daily
    MV: T0-T5
    Mortality (+ cause): T2-T5, T7, T8
    RRT: T2-T5
    new RRT after POD 7 or H- discharge: T7, T8
    IP intake, fluid in-/output, fluid bal: T0-T4
    T: T0, T2-T4
    HR, MAP, SAP, DAP, CVP: T0, T1 (at least q 30 min), T2-T4
    vol guide: during IP admin
    ABGA: T0 + T2 (all); T3 + T4 (only Hb, Hct, lactate)
    ScvO2: T0, T2, T3
    S Elyte: T0, T2, T3
    Maj compl: T3-T8
    Cystatine C:T0,T2-T8
    SCr:T0,T2,T3,T4,T7,T8
    DFGe sur la base de la cystatine C:T0,T2,T3,T4,T7,T8
    DFGe moyen sur la base de la cystatine C:T0,T2,T3,T4,T7,T8
    DFGe sur la base de la SCr:T0,T2,T3,T4,T7,T8
    AKIN & RIFLE:T0,T2,T3,T4,T7,T8
    Débit urinaire:T0,T2-T4
    Coagulation:T0,T2,T3
    PCr:T0,T2,T3
    EI[G]s/RI[G]s:T0-T8
    Perte sanguine–GR:T4 & perop:T2
    DDS-H, DDS-USI, Déclaré apte à quitter l’USI/l’H: par jour
    VA:T0-T5
    Mortalité (+cause):T2-T5,T7,T8
    TSR:T2-T5
    Nouveau TSR a JPO 7 ou à la sortie d’H:T7,T8
    Administration de liquide, Apport/élimination hydrique, Équilibre hydrique:T0-T4
    T:T0,T2-T4
    FC, PAS, PAM, PAD, PVC:T0,T1(toutes les 30 min minimum),T2-T4
    vol guide: a l’administration du produit
    GDS:T0+T2(tous); T3+T4(Hb, Ht, Lactate)
    SvcO2:T0,T2,T3
    ES:T0,T2,T3
    CPM:T3-T8
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA36
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Serbia
    E.8.7Trial has a data monitoring committee Yes
    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
    Day 90 after surgery ± 14 days
    jour 90 après la chirurgie ± 14 jours
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    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: 1500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 780
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-11-29. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state350
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 2280
    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)
    Not different from the expected normal treatment of the condition.
    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 Decision2018-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-07
    P. End of Trial
    P.End of Trial StatusOngoing
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