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    Summary
    EudraCT Number:2013-005533-20
    Sponsor's Protocol Code Number:VOLATILE10600
    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:2014-01-27
    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 number2013-005533-20
    A.3Full title of the trial
    VOLATILE ANESTHETICS TO REDUCE MORTALITY IN CARDIAC SURGERY. A MULTICENTRE RANDOMIZED CONTROLLER STUDY
    L'EFFETTO DEGLI ANESTETICI ALOGENATI SULLA SOPRAVVIVENZA AD UN ANNO DALL'INTERVENTO CARDIOCHIRURGICO. UNO STUDIO MULTICENTRICO RANDOMIZZATO CONTROLLATO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    We’re planning a large multicentre controlled randomized trial to demonstrate that volatile anesthetics vs TIVA can reduce 1 year mortality from 3% to 2% in patients undergoing CABG (either with or without cardiopulmonary bypass) and 30 days after surgery (co-primary endpoint) in patients undergoing coronary artery bypass grafting
    Lo studio randomizzato, multicentrico e intende paragonare due regimi anestesiologici (utilizzo di gas alogenati vs utilizzo di anestesia totalmente endovenosa “TIVA”) nell’intervento di bypass aortocoronarico (CABG) condotto con l’ausilio di circolazione extracorporea. Si vuole dimostrare la riduzione di mortalità a 1 anno dal 3% al 2% (endpoint primario) e a 30 giorni dall’intervento (endpoint co-primario) nei pazienti sottoposti a bypass aortocoronarico.
    A.3.2Name or abbreviated title of the trial where available
    VOLATILE 10600
    VOLATILE 10600
    A.4.1Sponsor's protocol code numberVOLATILE10600
    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 SponsorOSPEDALE SAN RAFFAELE IRCCS
    B.1.3.4CountryItaly
    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 supportGRANT MINISTERO DELLA SALUTE BANDO RICERCA FINALIZZATA 2010
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOSPEDALE SAN RAFFAELE IRCCS
    B.5.2Functional name of contact pointANESTESIA E RIANIMAZIONE CARDIOCHIR
    B.5.3 Address:
    B.5.3.1Street AddressVIA OLGETTINA 60
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number+390226437154
    B.5.5Fax number+390226436152
    B.5.6E-maillandoni.giovanni@hsr.it
    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 SEVOFLURANE
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER SPA
    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.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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 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 DESFLURANE
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER SPA
    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.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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 ISOFLURANE
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT SRL
    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.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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
    PATIENTS UNDERGOING CORONARY ARTERY BYOASS GRAFT SURGERY
    PAZIENTI SOTTOPOSTI A BYPASS AORTOCORONARICO
    E.1.1.1Medical condition in easily understood language
    CORONARY ARTERY BYPASS GRAFT SURGERY
    INERVENTO DI BYPASS AORTOCORONARICO
    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
    Reduce 1 year mortality from 3% to 2% in patients undergoing CABG
    RIDUZIONE DI MORTALITA' A 1 ANNO DALL'INTERVENTO DAL 3% AL 2%
    E.2.2Secondary objectives of the trial
    Reduce 30 days mortality
    RIDUZIONE DI MORTALITA' A 30 GIORNI DALL'INTERVENTO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age >18 years
    -written informed consent
    -scheduled procedures
    - planned isolated CABG (multiple bypass are allowed; planned combined intervention such as CABG plus valve surgery are not allowed)
    - età > 18 anni
    -consenso informato
    -procedura elettiva
    -CABG isolato (inclusi i bypass multipli, escluse le chirurgie combinate come CABG piu’ chirurgia valvolare)
    E.4Principal exclusion criteria
    -pregnancy
    -planned valve surgery or surgery on the aorta
    -planned locoregional anesthesia without general anesthesia
    -unstable or ongoing angina -recent (< 1 month) or ongoing acute myocardial infarction
    -use of sulfonylurea, theophylline or allopurinol
    -previous unusual response to an anesthetic agent -inclusion in other randomised controlled studies in the previous 30 days
    -any general anesthesia performed in the previous 30 days
    -emergency operation (not scheduled)
    -kidney or liver transplant in medical history
    -liver cirrhosis (Child B or C)
    chirurgia valvolare / aortica pianificata
    --anestesia loco regionale senza anestesia generale
    --angina instabile o in atto -
    -infarto miocardico acuto recente (<1 mese) o in atto
    --utilizzo di sulfoniluree, teofillina o allopurinolo
    --risposta anomala alla somministrazione di alogenati
    --inclusione in altri studi randomizzati negli ultimi 30 giorni
    --anestesia generale negli ultimi 30 giorni
    --chirurgia urgente / emergente
    --trapianto di rene / fegato
    --Cirrosi epatica (Child B o C)
    --gravidanza
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point of the study will be 1 year mortality (any cause)
    Riduzione della mortalità cardiaca a 1 anno dall'intervento
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 YEAR
    1 ANNO
    E.5.2Secondary end point(s)
    cardiac mortality at 30 days and at 1 year
    - rehospitalization during follow up period
    - intensive care unit stay and hospital stay
    mortalità cardiaca a 30 giorni e a 1 anno dall'intervento
    - nuovo ricovero ospedaliero durante il periodo di follow-up
    - tempo di permanenza in terapia intensiva e in ospedale
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days and 1 year
    30 GIORNI E 1 ANNO
    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 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 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 concerned8
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    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 state2500
    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)
    GOOD CLINICAL PRACTICE
    NORMALE PRATICA CLINICA
    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 Decision2014-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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