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    Summary
    EudraCT Number:2018-004552-37
    Sponsor's Protocol Code Number:18CH052
    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:2019-04-18
    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 number2018-004552-37
    A.3Full title of the trial
    Dose Study of Tranexamic Acid in Total Hip Replacement to Reduce Postoperative Hemoglobin Loss. A Phase 2 Randomized Double-blind Monocentric Study
    Etude de dose de l’acide tranexamique dans la prothèse totale de hanche pour réduire la perte d’hémoglobine post-opératoire. Etude de phase 2 randomisée en double aveugle monocentrique.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Etude de dose de l’acide tranexamique dans la prothèse totale de hanche
    Dose Study of Tranexamic Acid in Total Hip Replacement
    A.3.2Name or abbreviated title of the trial where available
    PRADO
    PRADO
    A.4.1Sponsor's protocol code number18CH052
    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 SAINT-ETIENNE
    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 SAINT-ETIENNE
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU SAINT-ETIENNE
    B.5.2Functional name of contact pointProject manager
    B.5.3 Address:
    B.5.3.1Street AddressBâtiment recherche - Hôpital Nord
    B.5.3.2Town/ citySAINT-ETIENNE
    B.5.3.3Post code42055
    B.5.3.4CountryFrance
    B.5.4Telephone number33177127655
    B.5.5Fax number33177127820
    B.5.6E-mailbeatrice.deygas@chu-st-etienne.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 Exacyl
    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 nameAcide tranexamique
    D.3.4Pharmaceutical form 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
    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
    Arthropathy of Hip
    arthroplastie de hanche
    E.1.1.1Medical condition in easily understood language
    total hip prosthesis
    pose de prothèse totale de hanche
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077058
    E.1.2Term Hip arthropathy
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate of the dose-response relationship of intravenous intravenous tranexamic acid administration in the total hip prosthesis on the reduction of perioperative hemoglobin loss.
    Evaluer la relation dose-effet d’une administration préopératoire intraveineuse d’acide tranexamique dans la prothèse totale de hanche sur la réduction de la perte d'hémoglobine péri-opératoire.
    E.2.2Secondary objectives of the trial
    - To evaluate the dose-concentration-response relationship (pharmacokinetic-pharmacodynamic)

    - To compare erythrocyte transfusion in patient groups between D1 (day of surgery) and D8.

    - To compare the proportion of patients with anemia less than 10 g / dl between patient groups between D1 and D8.

    - To compare the occurrence of a symptomatic thromboembolic event, a convulsive seizure or a death until D8 between the groups.
    - Evaluer la relation dose-concentration-effet (ou étude pharmacocinétique-pharmacodynamique). Cette étude complémentaire de l’étude de la relation dose/effet permettra de mieux comprendre le mode d’action de l’ATX. Cette relation pourra venir en complément de la relation dose/effet pour déterminer la dose mais aussi les modalités d’administration de l’ATX en déterminant par exemple des seuils biologiques de concentration ou d’effet fibrinolytique optimaux.

    - Comparer la transfusion érythrocytaire entre les groupes de patients entre J1 (jour de l’intervention chirurgicale) et J8.

    - Comparer la proportion de patients ayant une anémie inférieure à 10 g/dl entre les groupes de patients entre J1 et J8.

    - Comparer la survenue d’un évènement thrombo-embolique symptomatique, d’une crise convulsive ou d’un décès jusqu’à J8 entre les groupes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient requiring primary hip arthroplasty (less than 3 months)
    - Consent of the patient or a family member or the support person
    - Indication d’arthroplastie de hanche de première intention hors fracture de hanche récente (moins de 3 mois).
    - Sujet ayant donné son consentement de participation éclairé et signé à l’étude ou dont un membre de la famille ou la personne de confiance a donné un consentement éclairé et signé pour sa participation à l’étude.
    E.4Principal exclusion criteria
    - Contraindication to tranexamic acid
    - Contraindication to apixaban
    - Pregnancy
    - Patient receiving a curative anticoagulating treatment in the preoperative period
    - Bilateral or previous hip arthroplasty
    - Hemorrhagic surgery less than 2 weeks old
    - Patients présentant une contre-indication à l’ATX définie selon le Vidal® : allergie connue à l’acide tranexamique, antécédents de convulsions, thrombose veineuse ou artérielle aiguë, insuffisance rénale grave (clairance de la créatinine < 15 ml/min calculée selon la formule de Cockroft).
    - Patients présentant une contre-indication à la prévention thrombo-embolique veineuse par apixaban défini par le résumé des caractéristiques du produit : hypersensibilité à la substance active ou à l’un des excipients, saignement évolutif cliniquement significatif, atteinte hépatique associée à une coagulopathie et à un risque de saignement cliniquement significatif.
    - Patients bénéficiant d’un traitement anticoagulant à dose efficace en pré-opératoire.
    - Femme enceinte.
    - Prothèse de hanche par voie antérieure ou bilatérale.
    - Chirurgie hémorragique de moins de 2 semaines.
    - Patient précédemment inclus dans cette même étude
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of haemoglobin decrease in the perioperative period. It requires the sampling of haemoglobin before surgery and on the eighth postoperative day.
    Pourcentage de perte d’hémoglobine entre l’hémoglobine préopératoire et l'hémoglobine post-opératoire à J8.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 8
    Jour: 8 après l'inclusion du patient
    E.5.2Secondary end point(s)
    - For tranexamic acid pharmacokinetics, the outcome measure is the sampling of tranexamic blood concentration.

    - For tranexamic acid pharmacodynamics, the outcome is the sampling of D-Dimer levels.

    - For allogenic red blood cell transfusion, the outcome measure will be the percentage of patients that will receive the transfusion of at least one allogenic red blood cell unit in the perioperative period.

    - For severe anaemia (defined as a level of haemoglobin <10 gram by deciliter), the outcome measure will be the percentage of patients that will have at least one value of haemoglobin <10 gram by deciliter in the perioperative period.

    - For the incidence of symptomatic thrombotic events and death, the outcome measure is a combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death.

    - Upon the occurrence of a seizure, the endpoint is a clinical endpoint involving either the observation of a generalized tonic-clonic seizure or a partial seizure or absence with epilepsy confirmed by an electroencephalogram interpreted by a blind neurologist in the patient's inclusion group.
    - Pour la pharmacocinétique de l’acide tranexamique, le critère est la concentration plasmatique d’acide tranexamique mesurée par chromatographie liquide ultra haute performance couplée à un spectromètre de masse en tandem (UPLC MS/MS). Pour la pharmacodynamie de l’ATX, le dosage plasmatique des D-dimères sera mesuré.

    - Pour la transfusion érythrocytaire, le critère d’évaluation sera le pourcentage de patients ayant reçu une transfusion d’au moins un concentré érythrocytaire allogénique en péri-opératoire entre J1 (jour de la chirurgie) et le 7ème jour post-opératoire (J8).

    - Pour l’anémie inférieure à 10 g/dl, le critère d’évaluation sera la proportion de patients ayant au moins un dosage d’hémoglobine inférieur à 10 g/dl entre J1 et J8.

    - Pour :
    --> l’incidence des événements thrombo-emboliques symptomatiques et des décès à J8, le critère d’évaluation est un critère combiné regroupant les événements veineux (thrombose veineuse profonde ou embolie pulmonaire), les événements artériels (syndrome coronarien aigu, accident vasculaire cérébral ischémique et ischémie aiguë de membre inférieur) et les décès toutes causes confondues.
    --> la survenue d’une crise convulsive, le critère d’évaluation est un critère clinique comportant soit l’observation d’une crise tonico-clonique généralisée, soit une crise partielle ou une absence avec épilepsie confirmée par un électro-encéphalogramme interprété par un neurologue en aveugle du groupe d’inclusion du patient.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 8
    Jour: 8 après l'inclusion du patient
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    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 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 trial5
    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 years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days15
    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: 200
    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 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 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 state250
    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
    Aucuns
    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 Decision2019-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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