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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2013-000791-15
    Sponsor's Protocol Code Number:1308015
    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:2015-09-24
    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 number2013-000791-15
    A.3Full title of the trial
    Evaluation of postoperative administration of tranexamic acid on reducing blood loss after hip prothesis surgery.
    Evaluation de l’administration post-opératoire d’acide tranexamique sur la réduction des pertes sanguines après prothèse de hanche.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of postoperative administration of tranexamic acid on reducing blood loss after hip prothesis surgery.
    Evaluation de l’administration post-opératoire d’acide tranexamique sur la réduction des pertes sanguines après prothèse de hanche.
    A.3.2Name or abbreviated title of the trial where available
    étude PORTO
    A.4.1Sponsor's protocol code number1308015
    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 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 de Saint-Etienne
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Saint-Etienne
    B.5.2Functional name of contact pointFORT
    B.5.3 Address:
    B.5.3.1Street AddressURCIP, Maison de la Recherche, Hopital Nord
    B.5.3.2Town/ citySaint-Etienne
    B.5.3.3Post code42055
    B.5.3.4CountryFrance
    B.5.4Telephone number330477828374
    B.5.5Fax number330477127820
    B.5.6E-mailj.noel.fort@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 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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTranexamic Acid
    D.3.9.1CAS number 701-54-2
    D.3.9.2Current sponsor codeExacyl
    D.3.9.3Other descriptive nameTRANEXAMIC ACID
    D.3.9.4EV Substance CodeSUB11214MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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
    surgery for hip prosthesis or for hip prosthesis replacement
    chirurgie de pose ou de remplacement de prothèse de hanche
    E.1.1.1Medical condition in easily understood language
    hip prosthesis surgery
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10044088
    E.1.2Term Total hip replacement
    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
    The main objective is to compare the blood loss during a hip replacement surgery and during the next 4 days, between 2 groups. First group will receive 1g of tranexamic acid (Exacyl) before the surgery. Second group will receive 1g of tranexamic acid (Exacyl) before the surgery, and 1g in a 8h-perfusion during the surgery.
    L’objectif est de comparer les pertes sanguines péri-opératoires entre J1 (jour de la chirurgie) et J5 d’une chirurgie pour prothèse de hanche, entre deux groupes de patients. Le premier groupe bénéficiera d’une injection pré-opératoire de 1 gramme d’acide tranexamique. Le deuxième groupe recevra 1 gramme d’acide tranexamique pré-opératoire suivi d’1 gramme perfusé sur 8 heures.
    E.2.2Secondary objectives of the trial
    1. Compare, between the 2 groups, the blood loss during the surgery, during the first day after the surgery, and during the four days after the surgery.
    2. Compare, between the 2 groups, the erythrocyte transfusion during the four days after the surgery.
    3. Compare the occurrence of transfusion, symptomatic thrombotic event or death to J45 between the two patient groups.
    4. Estimate blood levels of tranexamic acid
    5. Identify risk factors for perioperative blood loss
    6. To evaluate the effect of blood levels on blood loss from a model of post-operative blood loss during the first 24 hours
    1. Comparer entre les deux groupes les pertes sanguines per-opératoires (entre le début de la chirurgie et la fin de chirurgie), pertes sanguines post-opératoires à J1 (entre la fin de chirurgie et 24 heure plus tard), pertes sanguines post-opératoires (entre la fin de chirurgie et J5)
    2. Comparer la transfusion érythrocytaire entre les deux groupes de patient entre J1 et J5
    3. Comparer la survenue d’une transfusion, d’un événement thrombotique symptomatique ou d’un décès jusqu’à J45 entre les deux groupes de patient.
    4. Estimer les concentrations sanguines d’acide tranexamique
    5. Déterminer des facteurs de risques des pertes sanguines péri-opératoires
    6. Evaluer l’effet des concentrations sanguines sur les pertes sanguines par modélisation des pertes sanguines post-opératoires au cours des 24 premières heures
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 18 or more
    - needing a hip replacement surgery
    - signed informed consent
    - Sujets majeurs affilié ou ayant droit d’un régime de sécurité sociale
    - 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
    - patients with contraindication to tranexamic acid
    - patients with contraindication to preventing veinous thromboembolism by Apixaban
    - patients with a preoperative effective dose anticoagulant
    - pregnant woman
    - patients présentant une contre-indication à l’AT définie selon le Vidal® : allergie connue à l’acide tranexamique, antécédents de convulsions, antécédent d’accident thrombotique artériel ou veineux confirmé, 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
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the calculated perioperative blood loss (between the begin of the surgery (day 1) and day 5).
    Le critère d’évaluation principal est le volume calculé des pertes sanguines (annexe 5) en péri-opératoire (entre le début de l’intervention et J5).(11)(35) Il nécessite le dosage de l’hémoglobine au début de l’intervention et à J5.
    E.5.1.1Timepoint(s) of evaluation of this end point
    hemoglobin at the beginning of the surgery D1 and at D5.
    dosage de l’hémoglobine au début de l’intervention et à J5.
    E.5.2Secondary end point(s)
    - the blood loss during the surgery
    - the postoperative blood loss, between the end of the surgery and the day after
    - the postoperative blood loss, between the end of the surgery (day 1) and day 5
    - for the transfusion, the percentage of patients receiving at least one transfusion between the end of the surgery (day 1) and day 5
    - for the incidence of symptomatic thromboembolic events and death at week 6, the endpoint is a composite endpoint consisting venous events (deep vein thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke ischemic acute lower limb ischemia) and death from all causes.
    - for the pharmacokinetics of tranexamic acid, the test is the plasma concentration of tranexamic acid
    - to determine the risk factors for calculated blood loss, the criterion will be the primary endpoint
    - to evaluate the effect of blood levels of blood loss, the criterion will be the postoperative blood loss measured in the surgical drain placed intraarticular until the 24th postoperative hour
    - perte sanguine per-opératoire (entre le début de la chirurgie et la fin de chirurgie). Elle nécessite le dosage de l’hémoglobine au début de l’intervention et en fin d’intervention.
    - perte sanguine post-opératoire jusqu’à J1 (entre la fin de chirurgie et 24 heures plus tard). Elle nécessite le dosage de l’hémoglobine en fin d’intervention et 24 heures après la fin de chirurgie.
    - perte sanguine post-opératoire (entre la fin de chirurgie et J5). Elle nécessite le dosage de l’hémoglobine en fin d’intervention et à J5
    - Pour la transfusion érythrocytaire, le critère d’évaluation sera le pourcentage de patients ayant reçu une transfusion d’au moins un culot globulaire allogénique en péri-opératoire entre J1 (jour de la chirurgie) et le 4ème jour post-opératoire (J5).
    - Pour l’incidence des événements thrombo-emboliques symptomatiques et des décès à 6 semaines, 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.
    - 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).(36)
    - Pour déterminer les facteurs de risques des pertes sanguines calculées, le critère à expliquer sera le critère d’évaluation principal. Les facteurs étudiés sont décrits en 8.2.
    - Pour évaluer l’effet des concentrations sanguines sur les pertes sanguines, le critère à expliquer sera la perte sanguine post-opératoire mesurée dans le drain chirurgical placé en intra-articulaire jusqu’à la 24ème heure post-opératoire. Ce drain devra être en aspiration. La mesure sera interrompue si le drain nécessite d’être mis en siphonage ou enlevé. Des mesures seront répétées et s’effectueront pendant les 24 premières heures postopératoires.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - hemoglobin at the beginning of the surgery D1, at the end of the surgery D1, at the day after the surgery (D2) and at D5
    - transfusion between the beginning of the surgery and day 5
    - thromboembolic events and death during 6 weeks after the surgery
    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 Yes
    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 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 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 years2
    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: 168
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 168
    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 state168
    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)
    no change from the expected normal treatment of that condition
    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 Decision2013-08-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
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