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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2017-004206-17
    Sponsor's Protocol Code Number:P160919J
    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:2018-04-09
    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 number2017-004206-17
    A.3Full title of the trial
    Not done
    Comparaison des effets rénaux des solutés de remplissage vasculaire PlASmalyte Viaflo et NaCl 0,9 % au cours de la réanimation de patients TRAUmatisés graves.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not done
    A.3.2Name or abbreviated title of the trial where available
    ASTRAU
    A.4.1Sponsor's protocol code numberP160919J
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailmyriem.carrier@aphp.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 PLASMALYTE VIAFLO
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER S.A.S
    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 namePLASMALYTE VIAFLO
    D.3.4Pharmaceutical form Solution for infusion
    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 INNPLASMALYTE VIAFLO
    D.3.9.3Other descriptive namePLASMALYTE VIAFLO, solution pour perfusion.
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 2
    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 CHLORURE DE SODIUM 0,9 %
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER SAS
    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 nameCHLORURE DE SODIUM 0,9 %
    D.3.4Pharmaceutical form Solution for infusion
    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 INNCHLORURE DE SODIUM 0,9 %
    D.3.9.3Other descriptive name CHLORURE DE SODIUM 0,9 %
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Not done.
    Patients traumatisés graves à risque d'insuffisance rénale aigue.
    E.1.1.1Medical condition in easily understood language
    Not done
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10044528
    E.1.2Term Traumatic injury
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Not done.
    Montrer chez des patients traumatisés graves à risque d'insuffisance rénale aigue, que l'utilisation exclusive d'un soluté cristalloïde isotonique balancé au cours des 5 premiers jours de prise en charge (Plasmalyte Viaflo) diminue l'incidence de l'insuffisance rénale aigue par rapport à l'utilisation exclusive de sérum salé isotonique (soluté non balancé).
    E.2.2Secondary objectives of the trial
    Not done.
    Montrer que l'administration exclusive d'un soluté cristalloïde isotonique balancé (Plasmalyte Viaflo) en comparaison avec le sérum salé isotonique (soluté non balancé) au cours des 5 premiers jours de réanimation des patients traumatisés graves est associée à :
    1/ Une diminution du delta de créatininémie entre la valeur de base et le maximum mesuré au cours du séjour en réanimation
    2/ Une diminution de la proportion de patients ayant recours à l'épuration extra-rénale et une diminution du temps passé en épuration extra rénale
    3/ Une diminution du nombre de produits sanguins labiles transfusés au cours du séjour en réanimation
    4/ Un plus grand nombre de jours vivant sans ventilation mécanique
    5/ Un plus grand nombre de jours vivant hors de réanimation
    6/ Une diminution de la mortalité.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Not done.
    - Patient traumatisé grave défini par la présence d'au moins un critère de Vittel
    - Indication à la transfusion d'un concentré érythrocytaire dans les 6 heures suivant le traumatisme (la transfusion de 250 mL de sang récupéré par cell saver en peropératoire ou de 250 mL de sang par autotransfusion d'un hémothorax dans les 6 heures sont également des critères d'éligibilité à l'inclusion dans l'étude).
    - Délais trauma-inclusion inférieur ou égal à 6 heures
    - Patient qui est en état de donner son accord de participation avec recueil du consentement ou patient inclus sous la clause d'urgence
    - Patient affilié à un régime de sécurité sociale
    E.4Principal exclusion criteria
    Not done.
    - Patients âgés de moins de 18 ans
    - Remplissage en pré-inclusion > 4 litres
    - Insuffisance rénale chronique dialysée
    - Participation à un autre essai clinique interventionnel dans les 28 jours qui suivent l'inclusion
    E.5 End points
    E.5.1Primary end point(s)
    Not done.
    - Critère d'évaluation principal :
    Présence d'une insuffisance rénale aigue stade 2 ou 3, évaluée à partir des chiffres de créatininémie et de diurèse selon la classification de KDIGO pendant le séjour en réanimation au cours de l'étude (5 premiers jours au maximum).

    - Critères d'évaluation secondaires :
    1/ Différence entre le pic de créatinine sérique recueilli au cours du séjour du patient en réanimation pendant les 5 premiers jours au maximum et la créatinine sérique de base en µmol.L-1.
    En pratique courante en réanimation, la mesure de la créatinine sérique est effectuée par prélèvement sanguin sur tube hépariné et adressé au laboratoire de biochimie en local pour mesure. Le rythme de mesure ou la périodicité de mesure de créatinine sérique n'est pas imposé puisqu'en pratique courante, les patients traumatisés graves bénéficient au minimum d'un prélèvement quotidien et ce pendant toute la durée de la phase à risque de défaillance d'organe.

    2/ Nécessité d'une épuration extra-rénale en réanimation au cours de l'étude et recueil du temps passé en épuration extra rénale.
    Nombre de patients pour lesquels un recours à l'épuration extrarénale est nécessaire (28 jours au maximum) rapporté au nombre total de patients inclus dans l'étude. Nombre de jours passés en épuration extra-rénale.

    3/ Nombre total de produits sanguins labiles (Concentrés érythrocytaires, Plasmas frais congelés, Concentrés plaquettaires d'aphérèse) administrés en réanimation par patient.
    Le nombre total de produits sanguins labiles transfusés (un concentré érythrocytaire = 1 unité, un plasma frais congelé = 1 unité, un concentré d'unités plaquettaires = 1 unité) est relevé au cours de l'étude (5 premiers jours maximum).

    4/ Nombre de jours vivant sans ventilation mécanique durant 28 jours au maximum.
    Chaque jour, le caractère ventilé ou non du patient est relevé. Le patient est considéré sans ventilation mécanique lorsqu'il passe une journée entière (24h00 au total) sans ventilation mécanique.

    5/ Nombre de jours vivant hors de réanimation durant les 28 premiers jours au maximum.
    Chaque jour pendant 28 jours, le caractère vivant ou non du patient est relevé. Il est considéré vivant hors de réanimation lorsqu'il passe une journée entière (24h00 au total) vivant, hors du service de réanimation.

    6/ Décès jusqu'à 28 jours après inclusion, rapportés au nombre total de patients inclus dans l'étude.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not done.
    E.5.2Secondary end point(s)
    Not done
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not done.
    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 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) 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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned9
    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
    LSLV
    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: 566
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 56
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-04-09. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    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 state622
    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
    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 Decision2018-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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