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    Summary
    EudraCT Number:2015-002499-26
    Sponsor's Protocol Code Number:2015-13
    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:2015-09-08
    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 number2015-002499-26
    A.3Full title of the trial
    Tranexamic acid to reduce blood loss in hemorrhagic caesarean delivery: a multicenter randomized double blind placebo
    controlled dose ranging study
    Impact de l’acide tranéxamique sur la réduction du saignement actif au cours des césariennes hémorragiques : étude multicentrique randomisée thérapeutique dose-effet double aveugle versus placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to determine tranxamic acid's effect on the bleedings that occurs within the haemorrhagic caesarean
    Etude visant à déterminer l'effet de l'acide tranéxamique sur les saignements survenant durant les césariennes hémorragiques
    A.3.2Name or abbreviated title of the trial where available
    TRACES
    TRACES
    A.4.1Sponsor's protocol code number2015-13
    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 SponsorCentre Hospitalier Régional et Universitaire de Lille
    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 supportMinistery of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospitalier Régional et Universitaire de Lille
    B.5.2Functional name of contact pointAramatoulaye SAMBOU
    B.5.3 Address:
    B.5.3.1Street Address2 avenue Oscar Lambret
    B.5.3.2Town/ cityLILLE
    B.5.3.3Post code59037
    B.5.3.4CountryFrance
    B.5.4Telephone number00330320444145
    B.5.5Fax number00330320445711
    B.5.6E-mailDRC@chru-lille.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.3.4Pharmaceutical 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
    Haemorrhagic ceaserean
    césarienne hémorragique
    E.1.1.1Medical condition in easily understood language
    Haemorrhages that occur during the ceaserean
    Hémorragies survenant durant la césarienne
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10036418
    E.1.2Term Postpartum hemorrhage
    E.1.2System Organ Class 100000004868
    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 assess the efficacy of two (standard and low) doses regimens intravenous bolus of tranexamic acid (1g and 0,5g), compared to placebo, to reduce the measured blood loss when administered at the onset of an active PPH during elective or emergent caesarean section.
    L’objectif primaire de l’étude est de mesurer l’efficacité de deux doses d’acide tranéxamique (TA) (dose standard : 1g et dose faible : 0,5g), administrées au début d’une hémorragie active, comparées au placebo pour réduire les pertes sanguines mesurées survenant au cours d’une césarienne hémorragique programmée ou urgente.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    to assess the impact of the two dose regimens of 1g and 0,5g TA on
    • the maternal morbidity observed by anemia, surgical interventional procedures rates, length of the cesarean section, general anesthesia rate, immediate and late transfusion rate, prohaemostatic products need, organ failures, intensive care admission rate and ICU duration, length of breast feeding and hospital stay until discharge and death,
    • The incidence of the potential side effects of tranexamic acid: seizures, visual disturbance and vomiting or thrombosis and renal failure.
    • the inhibition of the biological fibrinolysis
    • the pharmacological distribution of the product TA in the maternal blood, in uterus bleeding and urines.
    • The inhibition of the biological fibrinolysis as measured by D Dimers and PAP maximal peak
    Les objectifs secondaires sont:
    La mesure de l’impact de ces deux doses d’acide tranéxamique comparées au placebo sur
    • La réduction de la morbidité maternelle : anémie et besoin transfusionnel immédiat et retardé, besoins en produits pro hémostatiques, procédures invasives chirurgicales incluant l’hystérectomie, longueur de la césarienne, pourcentage d’anesthésie générale, pourcentage et longueur de l’hospitalisation en ICU et dans le service d’obstétrique. Défaillance d’organe, Pourcentage et durée de l’allaitement maternel et décès maternel.
    • L’incidence des effets secondaires potentiels de TA (connus pour de fortes doses ou craints) tels que flou visuel ou trouble de la vision des couleurs, vomissements et convulsions, thrombose veineuse ou insuffisance rénale.
    • L’inhibition de la fibrinolyse biologique mesurée par la réduction de l’augmentation des D Dimères et des PAP et du potentiel de génération de plasmine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Each patient experiencing a bleeding volume of more than 800 mL during an elective or emergent caesarean section
    - Patient covered by social security
    - patiente présentant un saignement de plus de 800mL au cours d’une césarienne programmée ou urgente.
    - Patiente assurée sociale
    E.4Principal exclusion criteria
    • Patient unable to consent and/or <18 years old and/or legally assisted (incapable people or specially protected mentioned on the article L1121-5 to L1121-8 will not be included in the study).
    • Previous deep vein thrombosis or seizures or any contraindication to tranexamic acid
    • Inherited haemorrhagic diseases, essentially the Von Willbebrand disease
    • Patient presenting with a severe Hellp syndrome (platelet count <50 000/m3) or renal failure prior to the caesarean section (RIFLE score>2)
    • Administration of TA before inclusion
    - Patiente incapable de donner son consentement (moins de 18 ans ou incompétente juridiquement)
    - Antécédent personnel de thrombose ou de convulsions
    - Patiente présentant un Hellp syndrome sévère (numération plaquettaire inférieure à 50 000/mm3) ou une insuffisance rénale préalable à la césarienne (score RIFLE >2)
    - Administration d’acide tranéxamique avant l’inclusion
    - Maladies hémorragiques constitutionnelles, essentiellement la maladie de Willebrand.
    - Personnes incapables et spécialement protégées mentionné dans l'article L1121-5 à L1121-8
    E.5 End points
    E.5.1Primary end point(s)
    Blood loss volume measured between inclusion and 6 hours after.
    Saignement mesuré entre T0 = inclusion et T360 = 6 heures plus tard.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood loss voume at time 6hours after inclusion
    Volume de sang mesuté au temps 6 heures after inclusion
    E.5.2Secondary end point(s)
    • The rate of surgical interventional procedures such as arterial ligature, or surgical compression of the uterine wall or internal compression balloon.
    • The intensity and rate postoperative anaemia: decrease of haemoglobin preoperative to day +2, nadir of haemoglobin, number of patients with haemoglobin <8g/dL or developing a decrease >4g/dL at any time .compared with the third trimester haemoglobin.
    • The immediate and late red blood cell transfusion and prohemostatic products infusion.
    • The CS length.
    • The rate of postoperative organ failures and length of intensive care hospitalization.
    • The length of breast feeding.
    • Death.
    • Side effects: nausea, vomiting, seizures, visual disturbances, renal failure, thrombosis.
    • D Dimers and haemostasis parameters specifically focused on the diagnosis and evolution of fibrinolysis.
    Déterminer selon le groupe (dose de TA administrée) :
    • L’intensité et la fréquence de l’anémie postpartum : diminution de l’hémoglobine entre la phase préopératoire et le matin du deuxième jour postpartum, nadir de l’hémoglobine, nombre de patientes ayant présenté une chute de l’Hb de plus de 4 g/dL a chacun des temps d’observation.
    • La fréquence de la transfusion de concentrés érythrocytaires, leur délai et le nombre de CGR ainsi que celle des produits prohémostatiques
    • L’incidence des procédures interventionnelles de tamponnement par ballon intrautérin, chirurgicales ou radiologiques invasives et/ou de l’hystérectomie et leur délai après l’inclusion
    • La longueur de la césarienne et la fréquence de l’anesthésie générale
    • La fréquence des défaillances d’organe postopératoire et la longueur de l’hospitalisation en ICU
    • La fréquence de l’allaitement maternel exclusif ou partiel à J2, J5 et J42
    • La fréquence des décès maternels
    • La fréquence des effets secondaires attribuables au produit
    • L’inhibition biologique de la fibrinolyse
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 hours after inclusion
    6 heures après inclusion
    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 No
    E.6.7Pharmacodynamic No
    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) 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 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 trial3
    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 concerned5
    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 Yes
    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 la dernière patiente
    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 months
    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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 Yes
    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
    Patients under general anesthesia
    Patiente sous anesthésie générale
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state342
    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 Decision2015-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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