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    Summary
    EudraCT Number:2009-016814-25
    Sponsor's Protocol Code Number:FIBHGM-10-02
    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:2009-12-03
    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 number2009-016814-25
    A.3Full title of the trial
    Estudio abierto, comparativo, aleatorizado, del uso de TachoSil en pacientes con riesgo de sangrado sometidas a cirugía mamaria
    A.4.1Sponsor's protocol code numberFIBHGM-10-02
    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 SponsorFundación para la Investigación Biomédica Hospital Gregorio Marañón
    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 Yes
    D.2.1.1.1Trade name TACHOSIL Esponja medicamentosa
    D.2.1.1.2Name of the Marketing Authorisation holderNYCOMED AUSTRIA GMBH
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Medicated sponge
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPLocal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTROMBINA HUMANA
    D.3.9.3Other descriptive nameTROMBINA HUMANA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number55000
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFIBRINOGENO HUMANO
    D.3.9.1CAS number 9001-31-4
    D.3.9.3Other descriptive nameFIBRINOGEN, HUMAN
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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) 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 Yes
    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 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
    Cirugía de cáncer de mama
    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
    Comparar la proporción de pacientes sometidas a mastectomías parciales con riesgo de hemorragia que podrían ser dadas de alta el mismo día de la cirugía entre el grupo tratado con TachoSil y el grupo control, utilizando como criterios de alta el cuestionario de alta de cirugía mayor ambulatoria, la presencia o ausencia de drenaje y el volumen de drenaje.
    E.2.2Secondary objectives of the trial
    ? Comparar la proporción de pacientes que podrían ser dados de alta los días 1, 2 y 3 después de la cirugía entre el grupo TachoSil y el grupo control.
    ? Comparar el porcentaje de complicaciones posoperatorias (hematoma, hemorragia, seroma, infección, celulitis, neuropatías, reintervención) entre el grupo TachoSil y el grupo control.
    ? Comparar los resultados de la valoración del bienestar posoperatorio, mediante un cuestionario realizado por la paciente a las 6 h y al alta, entre ambas grupos.
    ? Seguimiento de seguridad.
    ? Comparar los datos farmacoeconómicos entre ambos grupos (días de baja laboral tras la operación, necesidad de analgesia posquirúrgica, consultas ambulatorias posteriores a la cirugía, necesidad de pruebas complementarias).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. La paciente va a someterse a una mastectomía parcial electiva (lumpectomía, segmentectomía o cuadrantectomía) indicada en los siguientes supuestos:
    b. Tratamiento quirúrgico del cáncer de mama, aceptando como único procedimiento complementario la realización de biopsia selectiva de ganglio centinela (BSGC) dentro del mismo acto quirúrgico, siempre que no exista solución de continuidad entre ambas regiones anatómicas (mamaria y axilar). En los casos de ganglio centinela localizado en la cadena mamaria interna, se asume el mismo lecho quirúrgico mamario.
    c. Biopsia de lesiones sospechosas previo marcaje con arpón, que conlleven una extirpación amplia, para lo cual se establece como criterio de selección y de forma arbitraria, que al menos uno de los diámetros de la pieza sea igual o superior a 30 mm.
    d. Extirpación de lesiones benignas que impliquen una escisión mamaria amplia, para lo cual se establece como criterio de selección y de forma arbitraria, que al menos uno de los diámetros de la lesión sea igual o superior a 30 mm.
    2. Evidencia de riesgo de hemorragia, definido de la forma siguiente:
    ? Puntuación igual o mayor de 4 en el Condensed MCMDM-1VWD Bleeding Questionnaire propuesto por Bowman20 (Anexo 1).
    O bien,
    ? Puntuación igual a 3 en el Condensed MCMDM-1VWD Bleeding Questionnaire propuesto por Bowman20 y presencia de al menos uno de los siguientes factores de riesgo:
    - edad avanzada, > 65 años.
    - anemia preoperatoria, con una cifra de hemoglobina <11,5 g/dl
    - insuficiencia cardiaca congestiva, diagnosticada y en tratamiento médico.
    - enfermedad pulmonar obstructiva crónica (EPOC), diagnosticada por radiología convencional.
    - vasculopatía periférica,
    - diabetes mellitus, diagnosticada y en tratamiento
    - tratamiento anticoagulante o antiagregante previo, durante al menos el mes previo a la intervención.
    - insuficiencia hepática (con alteraciones en los parámetros de coagulación) o renal previa (con cifras de creatinina plasmática > 1,5 mg/dl).
    - hipertensión arterial (HTA), diagnosticada y en tratamiento.
    - quimioterapia previa a la cirugía (quimioterapia neoadyuvante)
    3. Paciente mujer mayor de 18 años.
    4. La paciente ha otorgado el consentimiento informado por escrito.
    E.4Principal exclusion criteria
    Criterios exclusión preoperatorios
    1. Mujeres embarazadas o en periodo de lactancia o que tengan previsto quedarse embarazadas durante el periodo del estudio.
    2. Cirugía de urgencia.
    3. Participación en otro ensayo clínico durante el periodo del estudio.
    4. Historial de reacciones alérgicas a la trombina y fibrinógeno humanos y/o al colágeno de cualquier origen.
    5. Pacientes en los que se conozca antes de la intervención que van a requerir una linfadenectomía axilar.

    Criterios exclusión intraoperatorios
    1. Necesidad de practicar una linfadenectomía axilar.
    2. Uso de sellador de fibrina o cualquier otro pegamento durante la cirugía.
    E.5 End points
    E.5.1Primary end point(s)
    Comparación entre los dos grupos de la proporción de pacientes que podrían recibir el alta el mismo día de la cirugía, utilizando como criterios de alta el cuestionario de alta de cirugía mayor ambulatoria, la presencia o ausencia de drenaje y el volumen de drenaje. El cuestionario de alta será cumplimentado por un mismo cirujano independiente, distinto del que practica la cirugía.
    El cuestionario de alta de cirugía mayor ambulatoria y el volumen de drenaje se recogerán a las 6 horas de la intervención.

    A efectos de este protocolo, los criterios de alta para la variable principal se definen de la forma siguiente:
    1. Ausencia de drenaje más una puntuación ? 9 en el cuestionario de alta de cirugía ambulatoria a las 6 horas después de la cirugía.
    2. En presencia de drenaje, la paciente estará preparada para recibir el alta siempre que el débito sea ? 10 ml más una puntuación de ? 9 en el cuestionario de alta de cirugía ambulatoria a las 6 horas de la cirugía.
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Tratamiento hemostático estándar
    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 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
    Última visita del último paciente
    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 months4
    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 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) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    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 state80
    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 Opinion2009-11-27
    P. End of Trial
    P.End of Trial StatusOngoing
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