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    Summary
    EudraCT Number:2019-004439-22
    Sponsor's Protocol Code Number:CHUBX2018/64
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-01-13
    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 number2019-004439-22
    A.3Full title of the trial
    TRAnexamic Acid for Preventing blood loss following a cesarean delivery in women with placenta pREVIA: a multicenter randomised, double blind placebo controlled trial (TRAAPrevia)
    L'acide tranéxamique en prévention de l'hémorragie du post-partum après
    césarienne associée à un placenta praevia. Etude contrôlée, en double aveugle, contre placebo, randomisée, multicentrique (TRAAPrevia).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TRAnexamic Acid for Preventing postpartum hemorrhage following a
    Cesarean Delivery in women with placenta praevia
    Acide tranéxamique, césarienne et placenta praevia
    A.3.2Name or abbreviated title of the trial where available
    TRAAPrevia
    A.4.1Sponsor's protocol code numberCHUBX2018/64
    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 Bordeaux
    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 supportNational French Program of Ministry of Health
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Bordeaux
    B.5.2Functional name of contact pointSophie Regueme
    B.5.3 Address:
    B.5.3.1Street AddressDirection de la Recherche Clinique et de l'Innovation. 12 rue dubernat
    B.5.3.2Town/ cityTalence cedex
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number33557821067
    B.5.5Fax number33556794926
    B.5.6E-mailsophie.regueme@chu-bordeaux.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 No
    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 nameexacyl 1g-10mL
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1197-18-8
    D.3.9.2Current sponsor codeTRANEXAMIC ACID
    D.3.9.3Other descriptive nameTRANEXAMIC ACID
    D.3.9.4EV Substance CodeSUB11214MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Postpartum hemorrhage, placenta previa, prevention, blood loss, transfusion
    Hémorragie postpartum , placenta previa, prévention, perte de sang, transfusion
    E.1.1.1Medical condition in easily understood language
    Postpartum hemorrhage
    Hémorragie postpartum
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10036417
    E.1.2Term Postpartum haemorrhage
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10036585
    E.1.2Term Pregnancy, puerperium and perinatal conditions
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effect of a low dose of TXA (1g) administered within 3 minutes after delivery of the child in addition to prophylactic uterotonic in women with placenta previa and cesarean delivery, versus placebo, on the incidence of red blood cell (RBC) transfusion between delivery of child and discharge from postpartum hospital stay
    Comparer l'effet d'une faible dose de TXA (1g) administrée dans les 3 minutes après l'accouchement de l'enfant en plus de l'utérotonique prophylactique chez les femmes avec placenta praevia et césarienne, par rapport au placebo, sur l'incidence de la transfusion de globules rouges (RBC) entre l'accouchement et la sortie de l'hôpital après l'accouchement
    E.2.2Secondary objectives of the trial
    To compare the effect of a low dose of TXA (1g) after cesarean delivery in women with placenta previa, versus placebo, on other markers of postpartum blood loss on
    • estimated blood loss (estimated and calculated)
    • mean shock index measured at 15, 30, 45, 60 and 120 minutes after birth, or if PPH occur
    • proportion of women requiring supplementary uterotonic treatment, iron sucrose perfusion until discharge, red blood cell units transfused
    • incidence of arterial embolisation or emergency surgery for PPH
    • incidence of maternal postpartum transfer to a higher level of care
    • proportion of breastfeeding at hospital discharge
    • maternal death for any cause
    • nausea, vomiting, phosphenes, dizziness
    • thromboembolic events and other severe unexpected adverse reactions
    • transfer to neonatal ICU, hospitalisation within 12 weeks after birth
    • women’s satisfaction and psychological status
    Comparer l’effet d’une administration d’une faible dose d’acide tranéxamique (1g) délivrée chez des femmes présentant un placenta praevia et accouchant par césarienne ; versus placebo sur les marqueurs de la perte sanguine en postpartum sur :
    • pertes sanguines (gravimétriques, calculées ou estimées)
    • paramètres hémodynamiques mesurés à 15, 30, 45, 60 et 120 minutes
    • proportion de femmes nécessitant un traitement utérotonique supplémentaire, perfusion de fer, transfusion de CGR,
    • proportion de l’embolisation artérielle et de la chirurgie d’hémostase pour HPP.
    • proportion de transfert maternel en unité de soins intensifs ou service de réanimation
    • Proportion d’allaitement maternel
    • Décès maternel
    • Nausées, vomissements, phosphènes, vertiges
    • Evénements thromboemboliques
    • transfert en unité de néonatologie, hospitalisation dans les 12 semaines après la naissance
    • satisfaction et état psychologique auto-questionnaire à J2 et 8 semaines du post-partum
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age≥ 18 years
    • Placenta previa defined by a placental edge below 20mm from internal cervical os diagnosed at the most recent transvaginal ultrasound examination before delivery, as per French guidelines [2, 46].
    • Cesarean delivery before or during labor
    • Gestational age at delivery ≥ 32 weeks + 0
    • Affiliated or beneficiary to a health security system
    • Signed informed consent
    • Âge ≥ 18 ans
    • Placenta previa défini par un bord placentaire inférieur à 20 mm de l'orifice cervical interne diagnostiqué lors de l'échographie transvaginale la plus récente avant l'accouchement, selon les directives françaises.
    • Accouchement par césarienne avant ou pendant le travail
    • Âge gestationnel à l'accouchement ≥ 32 semaines + 0
    • Affilié ou bénéficiaire d'un système de sécurité sanitaire
    • Consentement éclairé signé
    E.4Principal exclusion criteria
    • History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, stroke) thrombotic event
    • History of epilepsy or seizure
    • Chronic or acute cardiovascular disease (including foramen oval, mitral stenosis, aortic stenosis, heart transplant, pulmonary hypertension)
    • Chronic or acute renal disease (including chronic or acute kidney failure with glomerular filtration rate <90 mL/min, renal transplantation)
    • Chronic active, or acute, liver disorder with hemorrhagic or thrombotic risk (including cirrhosis, portal hypertension, ASAT>3N, Budd-Chiari syndrome)
    • Active autoimmune disease with thromboembolic risk (including lupus, antiphospholipid syndrome, Crohn’s disease)
    • Sickle cell disease (homozygous)
    • Severe hemostasis disorder :
    -- Prothrombotic (Factor V Leiden mutation – homo or heterozygous; Activated protein C (APC) resistance Protein C deficiency, Protein S deficiency aside from pregnancy, Homocysteinemia,; Factor 2 mutation – homo or heterozygous; Deficiency in antithrombin 3),
    -- Prohemorragic such as von Willebrand disease requiring desmopressin treatment during delivery, Thrombocytopenia (< 30 000 /mm3), Glanzmann disease, hypofibrinogenemia (< 1 g/L) aside from pregnancy)
    • High prenatal suspicion of placenta accreta spectrum disorder according to the obstetrician in charge
    • Abruptio placentae
    • Significant bleeding (estimated blood loss > 500ml) within 12 hours before cesarean delivery
    • Eclampsia / HELLP syndrome
    • In utero fetal death
    • Administration of low-molecular-weight heparin or antiplatelet agents during the 7 days before delivery
    • Hypersensitivity to tranexamic acid or sodium chloride
    • Poor understanding of the French language
    • Antécédents d'événement thrombotique veineux (thrombose veineuse profonde et / ou embolie pulmonaire) ou artériel (angine de poitrine, infarctus du myocarde, accident vasculaire cérébral)
    • Antécédents d'épilepsie ou de convulsions
    • Maladie cardiovasculaire chronique ou aiguë (y compris foramen ovale, sténose mitrale, sténose aortique, transplantation cardiaque, hypertension pulmonaire)
    • Insuffisance rénale chronique ou aiguë (y compris insuffisance rénale chronique ou aiguë avec un taux de filtration glomérulaire <90 ml / min, transplantation rénale)
    • Troubles hépatiques chroniques actifs ou aigus avec risque hémorragique ou thrombotique (y compris cirrhose, hypertension portale, ASAT> 3N, syndrome de Budd-Chiari)
    • Maladie auto-immune active avec risque thromboembolique (y compris lupus, syndrome des antiphospholipides, maladie de Crohn)
    • drépanocytose (homozygote)
    • Trouble grave de l'hémostase
    -- Prothrombotique (mutation du facteur V Leiden - homo ou hétérozygote; résistance à la protéine C activée (APC), carence en protéine C, carence en protéine S en dehors de la grossesse, homocystéinémie;; mutation du facteur 2 - homo ou hétérozygote; carence en antithrombine 3),
    -- Prohémorragiques telles que la maladie de von Willebrand nécessitant un traitement à la desmopressine pendant l'accouchement, la thrombocytopénie (<30 000 / mm3), la maladie de Glanzmann, l'hypofibrinogénémie (<1 g / L) en dehors de la grossesse)
    • Suspicion prénatale élevée de trouble du spectre du placenta accreta selon l'obstétricien en charge
    • Abruptio placentae
    • Saignement important (perte de sang estimée> 500 ml) dans les 12 heures précédant l'accouchement par césarienne
    • Syndrome d’éclampsie / HELLP
    • Mort fœtale in utero
    • Administration d'héparine de bas poids moléculaire ou d'agents antiplaquettaires pendant les 7 jours avant l'accouchement
    • Hypersensibilité à l'acide tranexamique ou au chlorure de sodium
    • Mauvaise compréhension de la langue française
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome of the trial is the incidence of red blood cell transfusion between delivery of child and discharge from postpartum hospital stay.

    We chose this primary outcome for the following reasons: Assessment of postpartum blood loss is difficult in the context of cesarean delivery, and its accuracy has been questioned, whatever the method used. Moreover, RBC transfusion is considered as a significant maternal morbidity equivalent of blood loss equal or superior to 1,000 mL and it is rare that a patient received RBC transfusion for a blood loss less than 1,000 ml. As such, it is included in the recently published core set outcomes recommended for studies evaluating interventions for PPH prevention. Finally, the reported incidence of RBC transfusion in the context of placenta previa is high enough for it to be used as a relevant primary outcome in our trial, with an achievable number of inclusions
    Le critère de jugement principal est l'incidence de la transfusion de globules rouges entre l'accouchement et la sortie de l'hôpital après l'accouchement.

    Nous avons choisi ce résultat principal pour les raisons suivantes: l'évaluation de la perte de sang post-partum est difficile dans le contexte de l'accouchement par césarienne, et sa précision a été mise en doute, quelle que soit la méthode utilisée. De plus, la transfusion de GR est considérée comme une morbidité maternelle significative équivalente à une perte de sang égale ou supérieure à 1000 ml et il est rare qu'un patient ait reçu une transfusion de GR pour une perte de sang inférieure à 1000 ml. En tant que tel, il est inclus dans les résultats d'ensemble de base récemment publiés recommandés pour les études évaluant les interventions pour la prévention de l'HPP. Enfin, l'incidence rapportée de transfusions de globules rouges dans le contexte du placenta praevia est suffisamment élevée pour qu'elle puisse être utilisée comme critère de jugement principal pertinent dans notre essai, avec un nombre réalisable d'inclusions
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline
    Baseline
    E.5.2Secondary end point(s)
    • Relative to postpartum blood loss
    - gravimetrically estimated and calculated blood loss,
    - calculated blood loss > 1500 ml and > 1000 mL.
    - provider-assessed clinically significant PPH
    - shock index, defined by the ratio of heart rate to systolic blood pressure, measured at 15, 30, 45, 60 and 120 minutes after birth, or if PPH occurs
    - supplementary uterotonic treatment
    - iron sucrose perfusion until discharge
    - number of red blood cell units transfused between delivery of child and discharge from postpartum hospital stay.
    - arterial embolisation or emergency surgery for PPH
    - maternal postpartum transfer to a higher level of care
    - breastfeeding at hospital discharge
    - maternal death for any cause

    - Hb within 7 days before delivery and at day 2 postpartum
    - Ht within 7 days before delivery and at day 2 postpartum

    • Relative to potential adverse reactions:
    - Occurrence of nausea, vomiting, phosphenes, dizziness ; these events will be collected up to hospital discharge);
    - Occurrence of thromboembolic events ; these events will be assessed up to 12 weeks after the delivery

    • Occurrence of neonatal outcomes: transfer to neonatal ICU.

    • Women’s satisfaction and psychological status:
    - self-administered questionnaire at day 2 postpartum
    - self-administered questionnaire at 8 weeks of postpartum,
    - questionnaire at 12 weeks of postpartum
    • Relatif à la perte de sang post-partum
    - perte de sang estimée et calculée par gravimétrie,
    - perte de sang calculée> 1500 ml et> 1000 ml.
    - HPP cliniquement significative évaluée par le fournisseur
    - indice de choc, défini par le rapport de la fréquence cardiaque à la pression artérielle systolique, mesuré à 15, 30, 45, 60 et 120 minutes après la naissance, ou en cas de HPP
    - traitement utérotonique supplémentaire
    - perfusion de saccharose fer jusqu'à la sortie
    - nombre d'unités de globules rouges transfusées entre l'accouchement et la sortie de l'hôpital après l'accouchement.
    - embolisation artérielle ou chirurgie d'urgence pour l'HPP
    - transfert maternel post-partum à un niveau de soins plus élevé
    - allaitement à la sortie de l'hôpital
    - décès maternel quelle qu'en soit la cause

    - Hb dans les 7 jours avant l'accouchement et au jour 2 post-partum
    - Ht dans les 7 jours avant l'accouchement et au jour 2 post-partum

    • Relatif aux effets indésirables potentiels:
    - Apparition de nausées, vomissements, phosphènes, vertiges; ces événements seront collectés jusqu'à la sortie de l'hôpital);
    - Occurrence d'événements thromboemboliques; ces événements seront évalués jusqu'à 12 semaines après l'accouchement

    • Occurrence des issues néonatales: transfert en soin intensif néonatal.

    • Satisfaction et état psychologique des femmes:
    - questionnaire auto-administré au jour 2 post-partum
    - questionnaire auto-administré à 8 semaines du post-partum,
    - questionnaire à 12 semaines de post-partum
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, day 2, 8 and 12 week postpartum
    Baseline, jour 2, 8 et 12 semaines postpartum
    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 Yes
    E.6.4Safety Yes
    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) 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 concerned31
    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
    DVDP
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 1380
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state1380
    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
    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 Decision2020-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-05
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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