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    Summary
    EudraCT Number:2012-002328-34
    Sponsor's Protocol Code Number:KB056
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-05-19
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-002328-34
    A.3Full title of the trial
    Efficacy and safety evaluation of Kedrion Fibrin Sealant as an adjuvant for the control of hemostasis in pediatric patients undergoing abdominal or orthopedic surgery. Multicenter, randomized, controlled open label, phase III study
    Valutazione dell’Efficacia e della Sicurezza della Colla di Fibrina Kedrion come coadiuvante per il controllo dell’emostasi in pazienti pediatrici sottoposti ad interventi di chirurgia addominale o ortopedica. Studio multicentrico, controllato, randomizzato, prospettico, in aperto di Fase III.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and safety evaluation of Kedrion Fibrin Sealant as an adjuvant for the control of hemostasis in pediatric patients undergoing abdominal or orthopedic surgery. Multicenter, randomized, controlled open label, phase III study
    Valutazione dell’Efficacia e della Sicurezza della Colla di Fibrina Kedrion come coadiuvante per il controllo dell’emostasi in pazienti pediatrici sottoposti ad interventi di chirurgia addominale o ortopedica. Studio multicentrico, controllato, randomizzato, prospettico, in aperto di Fase III.
    A.4.1Sponsor's protocol code numberKB056
    A.5.4Other Identifiers
    Name:Valutazione dell’Efficacia e della Sicurezza dellaNumber:valuation of Efficacy and Safety of Kedrion Fibrin
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/20/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKEDRION S.P.A
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsor
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKedrion S.P.A
    B.5.2Functional name of contact pointMedical & Scientific Information
    B.5.3 Address:
    B.5.3.1Street AddressLocalità Ai Conti
    B.5.3.2Town/ cityCastelvecchio Pascoli, Lucca
    B.5.3.3Post code55051
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 0583 1969603
    B.5.5Fax number+39 0583 1969277
    B.5.6E-mailmedinfo@kedrion.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP Role
    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 No
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.1Product nameColla di fibrina kedrion
    D.3.4Pharmaceutical form Powder and solvent for sealant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpilesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFIBRINOGENO UMANO LIOFILIZZATO
    D.3.9.1CAS number 9001-32-5
    D.3.9.2Current sponsor codeE03FB0313
    D.3.9.3Other descriptive nameHUMAN FIBRINOGEN
    D.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number42 to 78
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTHROMBIN
    D.3.9.1CAS number 9002-04-4
    D.3.9.2Current sponsor codeE01TB0113
    D.3.9.3Other descriptive nameTROMBINA
    D.3.9.4EV Substance CodeSUB15544MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1000 to 1562
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAPROTININA
    D.3.9.1CAS number 9087-70-1
    D.3.9.2Current sponsor code9103734
    D.3.9.3Other descriptive nameAPROTININ
    D.3.9.4EV Substance CodeSUB05546MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.74 to 1.11
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLORURO DI CALCIO
    D.3.9.2Current sponsor codeL0313
    D.3.9.3Other descriptive nameCLORURO DI CALCIO
    D.3.9.4EV Substance CodeSUB11767MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/l millimole(s)/litre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number250 to 300
    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 Yes
    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 Yes
    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.3.11.13.1Other medicinal product typeIl sistema di adesione della fibrina avvia l’ultima fase della coagulazione fisiologica del sangue
    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
    Paediatric patients undergoing abdominal or orthopedic surgery
    Pazienti pediatrici sottoposti a interventi di chirurgia addominale o ortopedica
    E.1.1.1Medical condition in easily understood language
    Paediatric patients undergoing abdominal or orthopedic surgery
    Pazienti pediatrici sottoposti a interventi di chirurgia addominale o ortopedica
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10067439
    E.1.2Term Haemostasis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Effective Primary Objectives:
    1) To evaluate the efficacy of Kedrion fibrin glue used as an adjuvant in hemostasis in pediatric patients undergoing abdominal or orthopedic surgery.
    The superiority of Kedrion Fibrin Glue to the standard treatment will be assessed using the Cochran-Mantel-Haenszel test, adjusting for age site and type of surgery.
    Safety Objectives Primary:
    1) To Eealuate the Safety of kedrion Fibrin glue used as an adjuvant in hemostasis in pediatric patients undergoing abdominal or orthopedic surgery for the duration of the study.
    Obiettivi di Efficacia Primaria:
    1)Valutare l’efficacia della Colla di Fibrina Kedrion usata come coadiuvante nell’emostasi in pazienti pediatrici sottoposti ad interventi di chirurgia addominale o ortopedica.
    La superiorità della Colla di Fibrina Kedrion verso il Trattamento Standard sarà valutata usando il Cochran–Mantel–Haenszel test, aggiustato per gruppo di età, centro e tipo di intervento chirurgico.
    Obiettivi di Sicurezza Primaria:
    1)Valutare la sicurezza della Colla di Fibrina Kedrion usata come coadiuvante nell’emostasi in pazienti pediatrici sottoposti a interventi di chirurgia addominale o ortopedica per tutta la durata dello studio.

    E.2.2Secondary objectives of the trial
    Secondary efficacy objectives:
    1) To evaluate the efficacy of Kedrion fibrin glue in the control of blood loss during the intra- and post-operative period in pediatric patients undergoing abdominal or orthopedic surgery.
    1)Valutare l’efficacia della Colla di Fibrina Kedrion nel controllo delle perdite ematiche nel periodo intra e post-operatorio in pazienti pediatrici sottoposti a interventi di chirurgia addominale o ortopedica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males and females aged <18 years who will experience abdominal or orthopedic surgery; in the case of abdominal surgery, Kedrion Fibrin Glue will be applied at sites with bleeding oozing without foci of punctate bleeding.
    2. The subjects and their parents or authorized legal guardians must have received adequate information about the nature of the trial, to agree with the aims of the study and signing the informed consent form, the assent form (if applicable) and the authorization form to the processing of personal data approved by the Ethics Committee (EC).
    3. Subjects able to comply with the procedures of the Protocol, including follow-up visits.
    Note 1: It will be possible to include patients with either congenital or acquired bleeding disorders, and it is also allowed the inclusion of patients with chronic diseases
    1.Maschi e femmine di età < 18 anni che andranno incontro a chirurgia addominale o ortopedica; nel caso della chirurgia addominale, la Colla di Fibrina Kedrion verrà applicata nei siti con sanguinamento a nappo senza foci puntiformi di sanguinamento.
    2.I soggetti e i genitori degli stessi o i rappresentanti legali autorizzati devono aver ricevuto adeguate informazioni in merito alla natura della sperimentazione, essere d’accordo con gli scopi dello studio e aver firmato il modulo del consenso informato, il modulo di assenso (se applicabile) ed il modulo di autorizzazione al trattamento dei dati personali approvati dal Comitato Etico (CE).
    3. Soggetti in grado di ottemperare alle procedure previste dal protocollo, incluse le visite di follow-up.
    Nota 1: Sarà possibile includere anche i pazienti affetti da coagulopatie sia congenite che acquisite, e sarà ammessa anche l’inclusione di pazienti affetti da patologie di tipo cronico
    E.4Principal exclusion criteria
    . Use of other agents adhesives /sealants not provided for the Protocol;
    2. Presence of conditions that, in the opinion of the investigator, may interfere with the evaluation of the objective of the study or participation in the study;
    3. Previous exposure to products containing bovine aprotinin for less than 12 months (positive to bovine aprotinin antibodies );
    4. Known allergies to blood components;
    5. Participation in another clinical trial in the month preceding the start of the study (in the last 30 days the subject has taken other investigational drugs);
    6. Subjects who are pregnant.
    .Utilizzo di altri agenti adesivi/sigillanti non previsti dal protocollo;
    2.Presenza di condizioni che, a giudizio dello sperimentatore, potrebbero interferire con la valutazione dell’obiettivo dello studio o con la partecipazione allo studio;
    3.Precedente esposizione a prodotti contenenti aprotinina bovina da meno di 12 mesi(positività anticorpi anti-aprotinina bovina);
    4.Allergie note ad emoderivati e/o ad emocomponenti;
    5.Partecipazione ad un altro studio clinico nel mese precedente l’inizio dello studio (negli ultimi 30 giorni il soggetto ha assunto altri farmaci sperimentali);
    6.Soggetti in gravidanza.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoints 1) Percentage of patients achieving complete hemostasis within 4 minutes from the end of the application of Kedrion fibrin glue. The application of Kedrion Fibrin Glue and the following measuring 4 minutes begins when the patient has reached a sufficient hemostasis (scale score 3) at the surgical site. The measurement of timewill have to start from this point in the case of control, and at the end of the application of Kedrion fibrin glue in cases treated with Glue, and will last for 4 minutes. Hemostasis will be considered satisfactory if, during the four minutes, you will not require any additional surgery to control bleeding (stitches, bleeding, prolonged compression, application of topical agents). If the patient in 4 minutes will not achieve hemostasis, will be considered as a negative result. Primary endpoints of safety 1. Percentage of subjects who develop adverse events associated with treatment (Kedrion Fibrin Glue Treatment or Standard) until the Follow-up visit. 2. Percentage of subjects who develop allergic reactions and hypersensitivity associated with the application of Kedrion fibrin glue. 3. Percentage of subjects positive for antibodies against bovine aprotinin, measured during the Screening and Follow-up visits. 4. Percentages of subjects who develop thrombogenic effects (changes in the levels of fibrinogen, thrombin-antithrombin (TAT), prothrombin fragment F1 + 2, antithrombin III, D-dimer), measured during theScreening and Follow Up visits.
    Endpoints primari di Efficacia 1)Percentuale dei pazienti che raggiungono una completa emostasi entro 4 minuti dalla fine dell’applicazione della Colla di Fibrina Kedrion. L’applicazione della Colla di Fibrina Kedrion e la seguente misurazione dei 4 minuti ha inizio da quando il paziente ha raggiunto una sufficiente emostasi (scala a punteggio 3) a livello del sito chirurgico. La misurazione del tempo dovrà iniziare quindi da questo momento nei casi di controllo, e alla conclusione dell’applicazione della Colla di Fibrina Kedrion nei casi trattati con la Colla, e durerà 4 minuti. L’emostasi sarà da considerarsi soddisfacente se, durante i 4 minuti, non sarà richiesto nessun intervento di emostasi aggiuntivo (punti di sutura, coagulazione, compressione prolungata, applicazione di agenti topici). Se il paziente nei 4 minuti non raggiungerà l’emostasi, sarà considerato come un esito negativo. Le definizioni della scala di valutazione a 5 punti (eccellente, buona, sufficiente, scarsa, molto scarsa) riportata nell’articolo di Codispti et al., 2002 (14) sono le seguenti: 1.Eccellente: raggiunta una completa emostasi. Nessun sanguinamento visibile e gemizio. 2.Buona: leggera perdita di sangue ma adeguato controllo del sanguinamento. Non sono necessari prodotti addizionali o manovre emostatiche. 3.Sufficiente: sanguinamento moderato o perdite di sangue generalizzate. Richieste manovre emostatiche addizionali, probabilmente non necessaria somministrazione di prodotti emoderivati. 4.Scarso: sanguinamento moderato e continua perdita di sangue. Richieste sia manovre emostatiche addizionali sia prodotti emoderivati. 5.Molto scarsa: sanguinamento severo non controllato. Richiesti interventi chirurgici addizionali. Endpoints primari di Sicurezza 1.Percentuale di soggetti che sviluppano eventi avversi associati al Trattamento (Colla di Fibrina Kedrion o Trattamento Standard) fino alla visita di Follow up. 2.Percentuale di soggetti che sviluppano reazioni allergiche e di ipersensibilità correlate con l’applicazione della Colla di Fibrina Kedrion. 3.Percentuale di soggetti positivi per anticorpi contro l’aprotinina bovina, misurati durante la visita di Screening e di Follow up. 4.Percentuali di soggetti che sviluppano effetti di trombogenicità (alterazione nei livelli di Fibrinogeno, complesso trombina-antitrombina (TAT), frammento protrombinico F1+2, antitrombina III, D-Dimero), misurati durante le visite di Screening e di Follow Up.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint will be measured at Visit 1, Day 1 during the surgery when the patient has reached a sufficient hemostasis (scale score 3) at the surgical site. The measurement of time will have to start from this point in the case of control, and at the end of the application of Kedrion fibrin glue in cases treated with Glue, and will last for 4 minutes. The primary endpoints of safety will be detected at screening, at visit 1 (randomization / surgery, Day 1), visit 2 (post-operative period, days 1-2) and visit 3 (Follow-up, days 30-40).
    L’endpoint di efficacia primario verrà rilevato alla visita 1, Giorno 1 durante la chirurga, quando il paziente ha raggiunto una sufficiente emostasi (scala a punteggio 3) a livello del sito chirurgico. La misurazione del tempo dovrà iniziare quindi da questo momento nei casi di controllo, e alla conclusione dell’applicazione della Colla di Fibrina Kedrion nei casi trattati con la Colla, e durerà 4 minuti. Gli endpoint primari di sicurezza verranno rilevati allo screening, alla visita 1 (randomizzazione/chirurgia, Giorno 1), visita 2 (Periodo Post-operatorio,Giorni 1-2) e visita 3 (Follow up, giorni 30-40).
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints 1) Amount of bleeding (in ml), intra-operative and post-operative. 2) Measurement of CBC, Hb, Hct at 3, 6, 12 ± 1 and 24 ± 1 hours after surgery. 3) Amount of transfusion of Fresh Frozen Plasma (FFP), red blood cells and platelets during and after surgery. The need for transfusion should be detailed in the CRF reporting in addition to the minimum that is Hb Hct (respectively ≤ 8 g / dL and ≤ 24%), other specific patient conditions that support decision to carry out the transfusion in each case
    Endpoint Secondari di Efficacia 1)Quantità di sanguinamenti (in ml) intra-operatori e post-operatori. 2)Misura di CBC, Hb, Hct a 3, 6, 12 ± 1 e 24 ± 1 ore dalla chirurgia. 3)Quantità di trasfusioni di Fresh Frozen Plasma (FFP), globuli rossi e piastrine durante e dopo la chirurgia. La necessità di effettuare la trasfusione dovrà essere dettagliata in CRF riportando tra le motivazioni, oltre che i valori minimi sia di Hb che di Hct (rispettivamente ≤ 8 g/dL e ≤ 24%), anche altre condizioni specifiche del paziente che supportino la decisione di effettuare la trasfusione in ciascun caso venga effettuata.
    Endpoint Secondari di Efficacia 1) Quantità di sanguinamenti (in ml) intra-operatori e post-operatori. 2) Misura di CBC, Hb, Hct a 3, 6, 12 ± 1 e 24 ± 1 ore dalla chirurgia. 3) Quantità di trasfusioni di Fresh Frozen Plasma (FFP), globuli rossi e piastrine durante e dopo la chirurgia. La necessità di effettuare la trasfusione dovrà essere dettagliata in CRF riportando tra le motivazioni, oltre che i valori minimi sia di Hb che di Hct (rispettivamente ≤ 8 g/dL e ≤ 24%), anche altre condizioni specifiche del paziente che supportino la decisione di effettuare la trasfusione in ciascun caso venga effettuata.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints of safety will be measured at visit 1 (randomization / surgery, Day 1), time 2 (post-operative period, days 1-2).
    Gli endpoint secondari di sicurezza verranno rilevati alla visita 1 (randomizzazione/chirurgia, Giorno 1), visita 2 (Periodo Post-operatorio,Giorni 1-2).
    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) No
    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) No
    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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Last Visit / patient: 30-40 days from the date of the surgical procedure
    Last Visit/paziente: a 30-40 giorni dalla data della procedura chirurgica
    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 months12
    E.8.9.1In the Member State concerned days36
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days36
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 4
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 11
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 15
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 15
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 2015-05-19. 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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    patients under the first day of life
    pazienti minori fin dal primo giorno di vita
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    Patients will be followed from the time of study entry until the planned follow-up after 30-40 days of surgery at the site
    I pazienti saranno seguiti dal momento dell’arruolamento nello studio fino al follow-up previsto dopo 30-40 giorni dall’intervento presso gli Ambulatori del Centro
    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 Decision2015-06-05
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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