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    Summary
    EudraCT Number:2018-000411-24
    Sponsor's Protocol Code Number:29BRC18.0034
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-03-16
    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 number2018-000411-24
    A.3Full title of the trial
    Reduction of bleeding during abdominal plastids with Exacyl®
    RESPA : Réduction grâce à l’Exacyl® du saignement au cours des plasties abdominales.
    A.3.2Name or abbreviated title of the trial where available
    RESPA
    A.4.1Sponsor's protocol code number29BRC18.0034
    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 SponsorCHRU de Brest
    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 supportATPCBO
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHRU de Brest
    B.5.2Functional name of contact pointFlorence MORVAN
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Foch
    B.5.3.2Town/ cityBrest Cedex
    B.5.3.4CountryFrance
    B.5.4Telephone number0033298223319
    B.5.5Fax number0033298223183
    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 Exacyl® 0.5 g/5 ml
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis
    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 nameTranexamic acid
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Les pertes sanguines péri-opératoires lors de la réalisation d'une dermolipectomie abdominale antérieure chez les patients ayant bénéficiés d’une chirurgie bariatrique.
    E.1.1.1Medical condition in easily understood language
    abdominoplastie
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10064703
    E.1.2Term Dermolipectomy
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l’impact de l’utilisation en péri-opératoire de l’acide tranéxamique versus placebo sur les pertes sanguines dans les dermolipectomies abdominales antérieures dans la population post-bariatrique, ainsi que sur le risque de réintervention, notamment pour hématome, dans les 10ers jours postopératoires.
    E.2.2Secondary objectives of the trial
    Evaluation dans le groupe actif versus placebo du :
    • Risque transfusionnel
    • Risque infectieux
    • Risque thrombotique artériel et veineux
    • Impact socio-économique : durée d’hospitalisation et d’arrêt de travail
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients :
    • De plus de 18 ans
    • Ayant bénéficié d’une chirurgie bariatrique (sleeve gastrectomie, by pass ou anneau gastrique)
    • Allant être opéré d’une dermolipectomie abdominale antérieure (abdominoplastie)
    • Acceptant de participer à l’étude
    • Affiliés à un régime de protection sociale
    E.4Principal exclusion criteria
    • Contre-indication à l’emploi de l’acide tranéxamique :
    - Pathologie artérielle ischémique (angor, infarctus du myocarde, syndrome coronarien aigu, accident vasculaire cérébrale)
    - Antécédents thromboemboliques veineux
    - Insuffisance rénale sévère (Clairance < 30ml/mn)
    - Patients épileptiques ou ayant un antécédent de convulsion
    • Troubles cognitifs ne permettant pas l’obtention d’un consentement éclairé
    • Refus de participation à l’étude
    • Allergies à un des produits
    • Patient traité par antiagrégant plaquettaire à une posologie de plus de 125mg/j
    • Abdominoplastie associée à une lipoaspiration > 200 ml
    • Patient avec un indice de masse corporel > 35 kg/m²
    • Patient majeur protégé (curatelle/tutelle)
    • Femme enceinte et/ou qui allaite
    E.5 End points
    E.5.1Primary end point(s)
    Les critères de jugement sont hiérarchisés dans l’ordre prédéfini suivant, afin de pouvoir réaliser une analyse hiérarchique permettant de contrôler le risque global de première espèce sur l’ensemble des comparaisons (Points to consider on multiplicity issues in clinical trials, EMEA 2002, CPMP/EWP/908/99) :
    1) Pertes sanguines totales en ml de globules rouges (PST)
    2) Reprise chirurgicale pour hématome dans les 10 premiers jours opératoires
    Les pertes sanguines totales en ml de globules rouges (PST) calculées par la formule de Mercuriali en 100% d’hématocrite ramenées ensuite en ml de sang total à 35% d’Ht :
    PST à 35% d’Ht = [Pertes sanguines non compensées par la transfusion + Pertes sanguines compensées par la transfusion (homologue)] x 0,35
     Pertes sanguines non compensées par la transfusion = VST×(Ht J-1 − Ht J+2) selon la Formule de Bourke, Anesthesiology 2000
    • VST = Volume Sanguin Total en ml à 35% d’hématocrite selon la règle de 5 de Gilcher (AFFSAPS 2002)
    • Ht J-1 = Hématocrite la veille de l’intervention
    • Ht J+2 = Hématocrite au 2ème jour post opératoire.

     Pertes sanguines compensées par la transfusion en péri-opératoire (pendant l’intervention et jusqu’à la sortie du service) = Volume en ml de produits sanguins transfusés x Ht admise par convention pour le type de produit sanguin considéré

    Pour les CG Homologues = 60% d’Ht (valeur basée sur le dernier rapport de conformité des produits sanguins délivrés par le CTS de Brest)
    E.5.1.1Timepoint(s) of evaluation of this end point
    J2
    E.5.2Secondary end point(s)
    • Nombre de transfusions effectuées pendant l’hospitalisation (bloc et service)
    • Complications infectieuses locales
    • Survenue d’évènements thromboemboliques artériel ou veineux
    • Durée d’hospitalisation
    • Durée d’arrêt de travail
    E.5.2.1Timepoint(s) of evaluation of this end point
    J2 - J10, 1 mois et 2 mois
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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) No
    E.8.2.2Placebo Yes
    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 concerned9
    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 years1
    E.8.9.1In the Member State concerned months8
    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.1.2.1Number of subjects for this age range: 432
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state442
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 442
    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
    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 Decision2018-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
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