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    Summary
    EudraCT Number:2020-000039-33
    Sponsor's Protocol Code Number:2018-06-017
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-04-20
    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 number2020-000039-33
    A.3Full title of the trial
    Multicentric, double-blind, randomized study to show that the addition of IV tranexamic acid versus placebo in ACL ligamentoplasties leads to a decrease in blood loss and postoperative pain
    Etude multicentrique randomisée en double aveugle visant à montrer que l’adjonction d’acide tranexamique IV versus placebo dans les ligamentoplasties du LCA entraine une diminution de la perte sanguine et des douleurs postopératoires
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    l’adjonction d’acide tranexamique IV versus placebo dans les ligamentoplasties du LCA entraine une diminution de la perte sanguine et des douleurs postopératoires
    the addition of IV tranexamic acid versus placebo in ACL ligamentoplasties leads to a decrease in blood loss and postoperative pain
    A.3.2Name or abbreviated title of the trial where available
    EXACYLCA
    EXACYLCA
    A.4.1Sponsor's protocol code number2018-06-017
    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 SponsorGroupement de Coopération Sanitaire Ramsay Générale de Santé pour l’Enseignement et la Recherche
    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 supportGroupement de Coopération Sanitaire Ramsay Générale de Santé pour l’Enseignement et la Recherche
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationECTEN
    B.5.2Functional name of contact pointBARBA
    B.5.3 Address:
    B.5.3.1Street Address81 rue Rosa Bonheur
    B.5.3.2Town/ cityLA ROCHETTE
    B.5.3.3Post code77000
    B.5.3.4CountryFrance
    B.5.6E-mailmh.barba@ecten.eu
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 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 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 infusion
    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
    Patients undergoing primary ACL ligamentoplasty with hamstring tendon removal on an outpatient basis
    Patients bénéficiant d’une ligamentoplastie primaire du LCA avec prélèvement des tendons des ischio-jambiers effectué en ambulatoire
    E.1.1.1Medical condition in easily understood language
    Patients undergoing primary ACL ligamentoplasty with hamstring tendon removal on an outpatient basis
    Patients bénéficiant d’une ligamentoplastie primaire du LCA avec prélèvement des tendons des ischio-jambiers effectué en ambulatoire
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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
    To evaluate the effect of IV tranexamic acid on the loss of hemoglobin on D2 in patients undergoing primary ACL ligamentoplasty with hamstring tendon sampling performed on an outpatient basis.
    Evaluer l’effet de l’acide tranexamique en IV sur la perte d’hémoglobine à J2 chez des patients bénéficiant d’une ligamentoplastie primaire du LCA avec prélèvement des tendons des ischio-jambiers effectué en ambulatoire.
    E.2.2Secondary objectives of the trial
    -Evaluate the effect of IV tranexamic acid on the loss of hemoglobin on D5 and M1 in patients undergoing primary ACL ligamentoplasty with hamstring tendon removal on an outpatient basis.
    - Evaluate the effect of IV tranexamic acid on the formation of a hematoma on D0, D5 and D12 in patients undergoing primary ACL ligamentoplasty with hamstring tendon sampling performed on an outpatient basis.
    -Evaluate the effect of IV tranexamic acid on pain on Day 0 (H1 and H6 post induction), from Day 1 to Day 12 and to Month 1
    -Evaluate the effect of IV tranexamic acid on the consumption of analgesics in the first 12 days following a primary ACL ligamentoplasty with removal of hamstring tendons performed on an outpatient basis.
    -Evaluate the effect of IV tranexamic acid on post-operative mobility at 1 month and 5 months in patients undergoing primary ACL ligamentoplasty with hamstring tendon sampling performed on an outpatient basis.
    -Evaluer l’effet de l’acide tranexamique en IV sur la perte d’hémoglobine à J5 et M1 chez des patients bénéficiant d’une ligamentoplastie primaire du LCA avec prélèvement des tendons des ischio-jambiers effectuée en ambulatoire.
    - Evaluer l’effet de l’acide tranexamique en IV sur la formation d’un hématome à J0, J5 et J12 chez des patients bénéficiant d’une ligamentoplastie primaire du LCA avec prélèvement des tendons des ischio-jambiers effectuée en ambulatoire.
    -Evaluer l’effet de l’acide tranexamique en IV sur la douleur à J0 (H1 et H6 post induction), de J1 à J12 et à M1
    -Evaluer l’effet de l’acide tranexamique en IV sur la consommation d’antalgiques dans les 12 premiers jours suivant une ligamentoplastie primaire du LCA avec prélèvement des tendons des ischio-jambiers effectuée en ambulatoire.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patient, male or female, over 18
    - Patient with an indication for primary ACL ligamentoplasty isolated +/- requiring an anterolateral plasty or meniscectomy / meniscal suture
    -Planned surgical procedure on an outpatient basis
    -Patient, homme ou femme, âgé de plus de 18 ans
    -Patient avec une indication chirurgicale de ligamentoplastie primaire du LCA isolé +/- nécessitant un geste de plastie antérolatérale ou de méniscectomie/suture méniscale
    -Procédure chirurgicale planifiée en ambulatoire
    E.4Principal exclusion criteria
    -Patient with a history of ACL surgery
    -Patient with a history of knee surgery other than meniscectomy
    -Patient with pluriligamentary lesions of the knee
    -Patient with a contraindication to the use of tranexamic acid: history of pulmonary embolism or deep vein thrombosis, stroke or TIA, myocardial infarction or coronary stent, subarachnoid hematoma
    -Patient with pathology of hemostasis or treatment with AVK or anticoagulants or taking hormone replacement therapy
    -Patient with hepatic impairment
    -Patient with renal insufficiency
    -
    -Patient ayant un antécédent de chirurgie du LCA
    -Patient ayant des antécédents de chirurgie du genou autre que la méniscectomie
    -Patient présentant des lésions pluriligamentaires du genou
    -Patient présentant une contre-indication à l’utilisation d’acide tranexamique : antécédents d’embolie pulmonaire ou de thrombose veineuse profonde, d’AVC ou d’AIT, d’infarctus du myocarde ou de stent coronarien, d’hématome subarachnoidien
    -Patient ayant une pathologie de l’hémostase ou un traitement par AVK ou anticoagulants ou prise d’un traitement hormonal de substitution
    -Patient ayant une insuffisance hépatique
    -Patient ayant une insuffisance rénale
    E.5 End points
    E.5.1Primary end point(s)
    The loss of hemoglobin between D0 (pre-operative, before any intervention) and Day 2 (post-operative), in absolute difference.
    La perte de l’hémoglobine entre J0 (en pré-opératoire, avant toute intervention) et J2 (post-opératoire), en différence absolue.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The main analysis of the primary endpoint is performed on the Intent to Treat Population. Very little missing data is expected. If however this should happen, the higher value imputation will be carried out, using a "missing = failure" approach.
    L’analyse principale du critère de jugement principal est réalisée sur la Population en intention de traiter . Très peu de données manquantes sont attendues. Si cependant cela devait arriver, l’imputation par plus grande valeur sera réalisée, dans une approche « missing = failure
    E.5.2Secondary end point(s)
    -the loss of hemoglobin on D5 and M1 will be evaluated by the difference in the dosage of hemoglobin at this time compared to Day 0
    -The formation of a hematoma on Day 0, Day 5 and Day 12 evaluated by a photograph of the lower limb operated on the anterior and posterior side at each time. The photographs will be reviewed by an independent speaker.
    -The consumption of analgesics will be assessed by the collection of analgesics using a patient diary
    -Post-operative mobility at 1 month and 5 months assessed using a goniometer by a single, independent practitioner.
    -The muscle recovery of the hamstrings and quadriceps at 5 months will be evaluated by an isokinetic test comparing the force of the operated leg against the force of the controlateral leg
    -Patient satisfaction at 5 months will be assessed using a satisfaction questionnaire
    -La perte d’hémoglobine à J5 et M1 sera évaluée par la différence du dosage de l’hémoglobine à ce temps par rapport à J0
    -La formation d’un hématome à J0, J5 et J12 évaluée par une photographie du membre inférieur opéré face antérieure et postérieure à chacun des temps. Les photographies seront revues par un intervenant indépendant.
    -La consommation d’antalgiques sera évaluée par le recueil des antalgiques à l’aide d’un carnet patient
    -Les mobilités post opératoires à 1 mois et 5 mois évaluées à l’aide d’un goniomètre par un intervenant unique et indépendant.
    -La récupération musculaire des ischio-jambiers et du quadriceps à 5 mois sera évaluée par un test isocinétique comparant la force de la jambe opérée contre la force de la jambe contro-latérale
    -La satisfaction des patients à 5 mois sera évaluée à l’aide d’un questionnaire de satisfaction
    - La tolérance sera évaluée par le recueil des événements indésirables
    E.5.2.1Timepoint(s) of evaluation of this end point
    Few missing data is expected on the main criterion.
    We assume a normal distribution of the main judgment criteria
    Très peu de données manquantes sont attendues sur le critère principal.
    On suppose une distribution normale du critère de jugement principal.
    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 Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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) Yes
    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 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 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 concerned2
    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 de suivi 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 months17
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state100
    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 plans de traitement ou de soins après que le sujet a mis fin à la participation à l'essai
    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 Decision2021-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2024-05-02
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