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    Summary
    EudraCT Number:2018-004300-19
    Sponsor's Protocol Code Number:18-PP-04
    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:2018-12-14
    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 number2018-004300-19
    A.3Full title of the trial
    Target-controled infusion with propofol in the Emergency Department : a prospective study on 50 adult patients
    Sédation Intraveineuse à Objectif de Concentration (SIVOC) au propofol à l’accueil des urgences : étude prospective pilote sur 50 patients consécutifs
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Target-controled infusion with propofol in the Emergency Department : a prospective study on 50 adult patients
    Sédation Intraveineuse à Objectif de Concentration (SIVOC) au propofol à l’accueil des urgences : étude prospective pilote sur 50 patients consécutifs
    A.3.2Name or abbreviated title of the trial where available
    SIVOC
    SIVOC
    A.4.1Sponsor's protocol code number18-PP-04
    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 SponsorCHU DE NICE
    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 supportCHU DE NICE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU DE NICE
    B.5.2Functional name of contact pointDEL CONT
    B.5.3 Address:
    B.5.3.1Street Address4 AVENUE REINE VICTORIA
    B.5.3.2Town/ cityNICE CEDEX 1
    B.5.3.3Post code06003
    B.5.3.4CountryFrance
    B.5.6E-maildelcont.d@chu-nice.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 propofol
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI FRANCE
    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.3.1Product namePROPOFOL
    D.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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
    Joint dislocation ; Limb displaced fracture
    Traumatisme de membre avec fracture ou luxation d’articulation
    E.1.1.1Medical condition in easily understood language
    Joint dislocation ; Limb displaced fracture
    Traumatisme de membre avec fracture ou luxation d’articulation
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10075886
    E.1.2Term Limb fractures and dislocations
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the brain concentrations necessary to reach the optimal sedation in patients with indications of very painful orthopedic emergency procedures
    déterminer les concentrations cérébrales de propofol nécessaires à l’obtention d’une sédation optimale, pour des soins très douloureux tels qu’une réduction de fracture déplacée ou de luxation d’articulation.
    E.2.2Secondary objectives of the trial
    Delays, lengths and levels of sedation obtained, overall delivered doses of propofol, nature, appearance delays and lengths of potential adverse events (AE), particularly complications related to procedural sedation, and necessary interventions to handle these AE, will be studied as secondary objectives
    délais, durées et niveaux de sédation obtenus ; doses totales de propofol administrées ; nature, délai d’apparition et durée des éventuels effets indésirables (EI) ; interventions nécessaires à la prise en charge de ces EI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age of 18 or more
    • Affiliated or beneficiary of a French health insurance system
    • Indication of procedural sedation by the emergency department physician in the context of the management of a patient with an orthopedic lesion requiring a potentially painful emergency therapeutic action (reduction of a joint dislocation or realignment of a limb displaced fracture)
    • Signed free informed consent or inclusion in the context of an emergency situation
    - majeur de plus de 18 ans
    - indication de sédation procédurale posée par le médecin urgentiste dans le cadre de la prise en charge d’un patient porteur d’une lésion orthopédique nécessitant un acte thérapeutique urgent potentiellement douloureux (réduction de luxation d’articulation ou réalignement d’un membre porteur d’une fracture déplacée)
    - obtention du consentement libre et éclairé du patient
    E.4Principal exclusion criteria
    • Patient of more than 18 under legal protection or deprivation of liberty measures
    • Ongoing pregnancy or breastfeeding women
    • Patient with the incapacity to give his free informed consent, excepted if the incapacity is induced by the context of the emergency situation (inclusion in the context of an emergency situation)
    • Known hypersensitivity to propofol or one of the excipients, egg, soja or peanuts
    • ASA comorbidity score of 4 or more
    • Heart, respiratory, renal or hepatic failure
    • Epilepsy
    • Lipid metabolism disorder
    • Mitochondrial disease
    • Hemodynamic instability, multiple traumatism
    • Elevated intracranial tension
    • Drug or alcohol intoxication
    - déclaration verbale par la patiente d’une grossesse connue en cours
    - incapacité de donner son consentement libre et éclairé
    - personne majeure faisant l’objet d’une protection légale, ou privée de liberté
    - non affiliation à la Sécurité Sociale
    - score de comorbidités ASA > 3
    - hypersensibilité connue au propofol ou à l'un des excipients
    - personne épileptique
    - personne présentant des troubles du métabolisme des lipides
    - personne présentant une pression intracrânienne élevée
    - personne souffrant d’insuffisance cardiaque, respiratoire, rénale ou hépatique
    - personne hypovolémique ou affaiblie
    - personne présentant une maladie mitochondriale
    - allergie à l’œuf ou au soja ou aux arachides
    - intoxication médicamenteuse ou alcoolique
    - instabilité hémodynamique et/ou polytraumatisme
    E.5 End points
    E.5.1Primary end point(s)
    Propofol brain concentration necessary for the patient to reach a Ramsay score of 5 (optimal sedation) (Ce_Ramsay5)
    concentration cérébrale de propofol en μg/ml ayant permis une sédation suffisante (Ramsay = 5) et permettant de réaliser confortablement le geste de réduction.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5) to be determined as a secondary outcome as described below (up to an anticipated average maximal value of 15 minutes after T0)
    entre le début de la sédation et le début de la procédure orthopédique (=score Ramsay =5)
    E.5.2Secondary end point(s)
    Delay between the beginning of sedation (T0) and the beginning of the orthopedic procedure (T_Ramsay5)
    délai de réveil après l’arrêt de la SIVOC
    E.5.2.1Timepoint(s) of evaluation of this end point
    the delay is the outcome, T_Ramsay5 (up to an anticipated average maximal time of 15 minutes after T0)]
    le temps de réveil après l'arrêt de la SIVOC
    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 No
    E.6.6Pharmacokinetic Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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.8.3 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
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial days1
    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 No
    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
    Patient that arrive in emergency department with limb joint dislocation or fracture
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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
    Aucun
    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 Decision2019-02-08
    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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