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    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   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:2009-016381-88
    Sponsor's Protocol Code Number:FEIV-DC-09
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-12-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-016381-88
    A.3Full title of the trial
    ESTUDIO PARA VALORAR LA SEGURIDAD Y LA EFICACIA DEL HIERRO ENDOVENOSO EN PACIENTES CON FRACTURAS DE CADERA EN LA PREVENCIÓN DE LA ANEMIA PERIOPERATORIA
    A.4.1Sponsor's protocol code numberFEIV-DC-09
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFUNDACIÓ PRIVADA CLÍNIC PER A LA RECERCA BIOMÈDICA
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Information not present in EudraCT
    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 nameFERIV
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNSACARATO HIERRO
    D.3.9.3Other descriptive nameSACARATO HIERRO
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeHierro trivalente, preparados parenterales, complejo hidróxido férrico-sacarosa
    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
    Anemia aguda postoperatoria
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10001016
    E.1.2Term Acute posthemorrhagic anemia
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Se plantea un objetivo principal compuesto de dos puntos que serán evaluados de forma jerárquica:
    1. Disminuir el consumo de hemoderivados y la tasa de transfusión sanguínea en pacientes mayores de 65 años que hayan sufrido una fractura de cadera o del extremo proximal del fémur, y que precisen de tratamiento quirúrgico.
    2. En caso de cumplirse lo anterior se evaluará, mediante un estudio farmacoeconómico, el impacto presupuestario que esta medida pudiese tener.
    E.2.2Secondary objectives of the trial
    • valorar la seguridad de la administración peroperatoria de hierro endovenoso
    • determinar el efecto diferencial entre los dos grupos de tratamiento en la evolución de los niveles de hemoglobina pre- y post- operatoria.
    • valorar si existe una disminución de las complicaciones y co-morbilidades postoperatorias, así como una reducción de las infecciones postoperatorias.
    • determinar si los pacientes que han recibido tratamiento con hierro endovenoso presentan una mejor recuperación funcional según el índice de Barthel y el cuestionario EuroQol-D5.
    • valorar las diferencias en la estancia hospitalaria y disminución de los reingresos entre los grupos.
    • reestimación de las tasas de mortalidad en el primer mes postoperatorio y a los 6 meses en ambos grupos.
    • Establecer, en función de los resultados, un protocolo de tratamiento y prevención de la anemia perioperatoria en pacientes con fractura de fémur.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) edad superior o igual de 65 años
    2) que presenten una fractura de cadera o del extremo proximal del fémur (fracturas subcapital, fractura pertrocantérea codificadas en el IDC9: 820.0, 820.2) ,
    3) que precisen de tratamiento quirúrgico. (Procedimientos IDC9: 78.55, 79.15, 79.35, 81.51, 81.52) y,
    4) que hayan firmado el consentimiento informado
    E.4Principal exclusion criteria
    1. Fractura patológicas tumorales
    2. Fracturas de dos o más huesos largos
    3. Cifras de ferritina sérica superiores a 300ng/ml (indicador de las reservas de hierro disponibles).
    4. Alergia a componentes de preparado de Hierro Sacarosa parenteral
    5. Rechazo manifiesto a transfusión alogénica
    6. Pacientes que reciben tratamiento con estimulantes eritropoyéticos.
    7. Pacientes que precisen transfusión en el momento del ingreso por anemia (niveles de Hemoglobina < 8 g/dl)
    8. Pacientes que precisen tratamiento anticoagulante endovenoso por alto riesgo tromboembólico
    9. Asma bronquial en tratamiento
    10. Cirrosis, hepatitis aguda o elevación de las transaminasas séricas tres veces por encima de los valores normales.
    11. Pacientes con demencia evolucionada según la Global Deterioration Scale (GDS): (GDS >5)
    E.5 End points
    E.5.1Primary end point(s)
    Se evaluará dos variables principales en una estrategia jerarquizada de manera que se testará la segunda con intención confirmatoria sólo si la primera es significativa:
    1. La necesidad de transfusión de concentrados de hematíes se evaluará comparando la tasa de transfusión (TS), el porcentaje de pacientes transfundidos entre ambos grupos.
    2. Sí se cumple lo anterior se relazará un estudio farmacoeconómico para evaluar impacto presupuestario que esta medida pudiese tener. Se estudiará los costes tangibles directos.
    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 Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Information not present in EudraCT
    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
    Se considerará concluido el ensayo cuando se haya reclutado el número suficiente de pacientes según el tamaño muestral calculado y que cada uno de ellos haya realizado un seguimiento clínico mínimo de 6 meses postquirúrgicos.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state360
    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 Decision2010-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
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