Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   37701   clinical trials with a EudraCT protocol, of which   6178   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).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2009-013056-71
    Sponsor's Protocol Code Number:TC-2402-038-SP
    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:2009-11-30
    Trial results View 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 number2009-013056-71
    A.3Full title of the trial
    Ensayo abierto, aleatorizado, multicentrico, controlado con grupo paralelo para evaluar la eficacia y seguridad de TachoSilâ frente a la práctica habitual en técnicas de sellado de duramadre para la prevención de la pérdida postquirúrgica de líquido cefalorraquídeo (LCR) en pacientes sometidos a cirugía de la base del cráneo.

    TachoSil versus current practice in dura sealing techniques for the prevention of postoperative cerebrospinal fluid (CSF) leaks in patients undergoing skull base surgery: An open label, randomised, controlled, multicentre, parallel group efficacy and safety trial.
    A.3.2Name or abbreviated title of the trial where available
    TASALL -TachoSil Against Liquor Leak
    A.4.1Sponsor's protocol code numberTC-2402-038-SP
    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 SponsorNycomed Danmark ApS
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorCommercial
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOther 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 IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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 mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.5
    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.IMP: 2
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOther 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 IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.5
    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 la base del cráneo para la prevención de la pérdida postquirúrgica de líquido cefalorraquídeo.

    Skull base surgery for the prevention of postoperative cerebrospinal fluid (CSF) leaks
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level PT
    E.1.2Classification code 10067908
    E.1.2Term Neurosurgery
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal es evaluar la eficacia de TachoSil como complemento para el sellado de la duramadre para evitar fugas postoperatorias de líquido cefalorraquídeo (LCR) y la formación de pseudomeningoceles clínicamente evidentes después de la cirugía de la base del cráneo.
    E.2.2Secondary objectives of the trial
    El objetivo secundario es evaluar la seguridad de TachoSil como complemento para el sellado de la duramadre para evitar fugas postoperatorias de LCR y la formación de pseudomeningoceles clínicamente evidentes después de la cirugía de la base del cráneo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Criterios preoperatorios de inclusión. Se requiere una respuesta positiva para la inclusión:
    1. ¿Se ha obtenido el consentimiento informado por escrito de conformidad con la normativa local antes de realizar cualquier actividad relacionada con el ensayo? (Se consideran actividades relacionadas con el ensayo todos los procedimientos que no se llevarían a cabo como parte del tratamiento habitual del paciente.)
    2. ¿Está capacitado y dispuesto el paciente a cumplir los procedimientos necesarios para la realización del ensayo?
    3. ¿Tiene el paciente 18 años o más?
    4. ¿Va el paciente a someterse a neurocirugía no relacionada con traumatismos para una afección de la base del cráneo que requerirá la apertura y el cierre de la duramadre? Se permite la sustitución de la duramadre.

    Criterios intraoperatorios de inclusión. Se requiere una respuesta positiva para la inclusión:
    5. ¿Tiene la herida quirúrgica una clasificación de clase I (herida quirúrgica limpia)?
    6. ¿Es el procedimiento/abordaje quirúrgico compatible con la cirugía de la base del cráneo? Es decir, cumple al menos uno de los siguientes requisitos:
    a. Abordaje lateral del agujero occipital: lateral lejano, extremo lateral, anterolateral, posterolateral.
    b. Abordaje del agujero yugular: infratemporal, yuxtacondíleo, transyugular.
    c. Abordaje del ángulo pontocerebeloso (PC) y del vértice de la porción petrosa retrosigmoideo, translaberíntico, retrolaberíntico, transcoclear (transpetroso limitado).
    d. Abordaje de la fosa media: subtemporal (+/- perforación del vértice petroso), abordaje pterional (cualquier abordaje frontotemporal +/- depósito orbitocigomático).
    e. Abordaje de la fosa anterior: subfrontal (unilateral o bilateral).
    f. Abordaje de la línea media o paramediano de la fosa posterior.
    E.4Principal exclusion criteria
    Criterios preoperatorios de exclusión. Se requiere una respuesta negativa para la inclusión:
    1. ¿Ha participado el paciente en otro ensayo clínico con un medicamento o dispositivo en investigación en los 28 días previos a la inclusión en este ensayo? (Se permite la participación en ensayos no intervencionistas.)
    2. ¿Ha participado anteriormente el paciente en este ensayo?
    3.¿Presenta el paciente algún signo de infección, tal como fiebre > 38,5 °C, leucocitos < 3,5x10^9/l o > 13,0 x10^9/l (si el paciente está recibiendo tratamiento con esteroides, hasta 20,00 x10^9/l), urocultivo positivo, hemocultivo positivo o radiografía de tórax positiva?
    4. ¿Padece el paciente una coagulopatía conocida?
    5. ¿Tiene el paciente antecedentes de reacciones alérgicas después de la aplicación del fibrinógeno humano, trombina humana o colágeno de cualquier origen?
    6. ¿Se prevé que el paciente requiera una nueva intervención neuroquirúrgica dentro del período de seguimiento de 7 ± 1 semanas en la misma área quirúrgica?
    En las mujeres con capacidad de concebir, es decir, ni posmenopáusicas (menos de 12 meses desde la última menstruación) ni esterilizadas permanentemente (por ejemplo, ligadura de trompas, histerectomía, salpingectomía bilateral):
    7. ¿Utiliza la paciente un método anticonceptivo inaceptable o un método ineficaz en el momento de la aleatorización, es decir, no utiliza un método anticonceptivo que sea un método de control de la natalidad de alta eficacia, definido como aquél que se asocia a una tasa de fracasos baja (es decir, menos del 1% al año) cuando se usa de forma sistemática y correcta, como implantes, anticonceptivos inyectables, anticonceptivos orales combinados, algunos dispositivos intrauterinos o la vasectomía de la pareja?
    8. ¿Ha tenido la paciente una prueba de embarazo en suero positiva hasta 5 días antes de la cirugía? Deberá realizarse una prueba de embarazo en suero a todas las mujeres en las que no se haya documentado la posmenopausia o la esterilización quirúrgica.
    9. ¿Está la paciente en período de lactancia?
    Criterios intraoperatorios de exclusión. Se requiere una respuesta negativa para la inclusión:
    10. ¿Es el abordaje/procedimiento quirúrgico compatible con cualquier abordaje transcraneal o transfacial o una combinación de abordajes transcraneal y transfacial con un defecto amplio en la base del cráneo? Es decir, cualquiera de los siguientes:
    g. Abordaje transbasal.
    h. Petrosectomía total.
    i. Abordaje transfacial.
    j. Abordaje transesfenoidal.
    k. Intervenciones endoscópicas.
    l. Abordaje transoral (y cualquier extensión: Le Fort, mandibulotomía).
    11. ¿Se ha mantenido intacta la aracnoides durante la cirugía y/o el sistema que contiene líquido?
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal será la aparición de una fuga de LCR clínicamente evidente o un seudomeningocele clínicamente evidente.
    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 No
    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) 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 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
    Práctica habitual para el cierre de la duramadre o duraplastia
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    El final del estudio se define como la 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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial 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 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 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 state168
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 550
    F.4.2.2In the whole clinical trial 726
    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 Decision2010-02-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-18
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2020 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA