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    Summary
    EudraCT Number:2016-004247-37
    Sponsor's Protocol Code Number:38RC16.046
    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:2017-05-04
    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 number2016-004247-37
    A.3Full title of the trial
    NA
    Impact de l’administration précoce de concentrés de complexe prothrombique chez les patients présentant une hémorragie post-traumatique grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    Impact de l’administration précoce de facteurs de coagulation chez les patients présentant une hémorragie post-traumatique grave
    A.3.2Name or abbreviated title of the trial where available
    NA
    PROCOAG
    A.4.1Sponsor's protocol code number38RC16.046
    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 SponsorUniversity Hospital Grenoble
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Grenoble
    B.5.2Functional name of contact pointprincipal investigator
    B.5.3 Address:
    B.5.3.1Street AddressPole anesthésie-réanimation
    B.5.3.2Town/ cityGRENOBLE
    B.5.3.3Post code38043
    B.5.3.4CountryFrance
    B.5.6E-mailpbouzat@chu-grenoble.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 KANOKAD 25 UI/ml de facteur IX, poudre et solvant pour solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderLFB-BIOMEDICAMENTS
    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 namekanokad
    D.3.4Pharmaceutical form Powder and solution for 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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboPowder and solvent for solution 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
    coagulopathy secondary to traumatic hemorrhagic shock
    coagulopathie secondaire à un choc hémorragique traumatique
    E.1.1.1Medical condition in easily understood language
    NA
    traumatisme
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    NA
    L’objectif principal de ce travail est de démontrer qu’une stratégie de correction rapide du déficit en facteurs de coagulation permet un arrêt plus précoce du saignement se traduisant par une réduction de la consommation en PSL.
    E.2.2Secondary objectives of the trial
    NA
    1. Analyse séparée du critère principal :
    - Evaluation de la consommation de CGR
    - Evaluation de la consommation de PFC
    - Evaluation de la consommation de Plaquettes

    Comparer entre les 2 groupes :

    2. Délais de normalisation de l’hémostase
    3. le délai d’arrêt du saignement défini lors d’une procédure chirurgicale et/ou radiologique
    4. les complications thrombo-emboliques
    5. le bénéfice économique de la nouvelle stratégie du point de vue de l’hôpital
    6. la morbi-mortalité
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    NA
    • Patient de plus de 18 ans
    • Admission primaire au déchocage pour un traumatisme grave
    • Patient ayant reçu une transfusion pré-hospitalière ou ayant reçu un CGR dans la 1ère heure suivant son admission au déchocage
    • Prédiction de transfusion massive par jugement clinique ou score ABC (Assessment of Blood Consumption) ≥ 2
    E.4Principal exclusion criteria
    NA
    • Patients mineurs
    • • ACR avant la randomisation au déchoquage
    • Transferts secondaires d’un autre centre hospitalier
    • Lésion post-traumatique hors de toute ressource thérapeutique avec décès attendu dans l’heure suivant l’admission hospitalière
    • Traitement par anticoagulants (AVK, nouveaux anticoagulants oraux)
    E.5 End points
    E.5.1Primary end point(s)
    NA
    Nombre de produits sanguins labiles transfusés (CGR, PFC et Plaquettes) en 24 heures après l’admission.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    24h
    E.5.2Secondary end point(s)
    NA
    1. Analyse séparée du critère principal :
    - Nombre de CGR transfusés dans les premières 24H
    - Nombre de PFC transfusés dans les premières 24H
    - Nombre de Plaquettes transfusés dans les premières 24H

    2. Mesure du temps pour atteindre la valeur cible en ratio Temps de Quick patient / TQ témoin < 1,5 (mesurée par le ratio TQ patient/témoin horaire de H1 à H6 puis H12 et H24)

    3. Mesure du délai entre le traumatisme et l’arrêt du saignement. L’arrêt du saignement est défini par le chirurgien lorsque le champ opératoire est sec sans procédure hémostatique supplémentaire prévisible et/ou par le radiologue interventionnel par l’arrêt du blush de produit de contraste en artériographie.

    4. Le nombre d’évènements thrombo-emboliques (embolie pulmonaire, thrombose veineuse profonde) pendant la durée du séjour en réanimation (sur suspicion clinique prouvée par écho doppler ou scanner)

    5. Mesure du coût de chacune des stratégies à J8 et à J28 (ou sortie de réanimation si après)

    6. Morbi-mortalité :
    - Mortalité à J28
    - Statut du patient vis à vis de l’hospitalisation à J28 (Domicile, SSR, Service médecine ou chirurgie, réanimation)
    - Durée de séjour en réanimation
    - Durée de ventilation mécanique
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    28 jours
    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 concerned12
    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
    NA
    La fin de l'étude est définie par la sortie à 28 jours du dernier patient inclus dans l'étude.
    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 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: 350
    F.1.3Elderly (>=65 years) No
    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 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 No
    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
    NA
    Les patients seront recrutés lors de l’admission hospitalière dès leur arrivée dans le service de déchocage des différents centres impliqués.

    Consentement éclairé signé d’un proche ou consentement d’urgence signé
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state350
    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)
    NA
    non
    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 Decision2017-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-08-31
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