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    Summary
    EudraCT Number:2017-003931-12
    Sponsor's Protocol Code Number:BXU513667
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-01-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-003931-12
    A.3Full title of the trial
    A Randomized Controlled Non-inferiority Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or Reducing Postoperative Air Leaks After Pulmonary Resection.
    Estudio aleatorizado, comparativo, de no inferioridad, para evaluar la eficacia y la seguridad de Hemopatch comparado con TachoSil en la prevención o reducción de las fugas de aire posquirúrgicas tras la resección pulmonar.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or Reducing Postoperative Air Leaks After Pulmonary Resection
    Estudio para evaluar la eficacia y la seguridad de Hemopatch comparado con TachoSil en la prevención o reducción de las fugas de aire posquirúrgicas tras la resección pulmonar.
    A.4.1Sponsor's protocol code numberBXU513667
    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 SponsorBaxter Healthcare Corporation
    B.1.3.4CountryUnited States
    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 supportBaxter Healthcare Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxter R&D Europe SPRL
    B.5.2Functional name of contact pointSr Clinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressBoulevard d'Angleterre 2-4
    B.5.3.2Town/ cityBraine l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32238 6961
    B.5.6E-mailmartin_kraft@baxter.com
    D. IMP Identification
    D.IMP: 1
    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 TachoSil sealant matrix
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Austria GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTachoSil
    D.3.4Pharmaceutical form Sealant matrix
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpilesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN FIBRINOGEN
    D.3.9.1CAS number 9001-32-5
    D.3.9.3Other descriptive nameHUMAN FIBRINOGEN
    D.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN THROMBIN
    D.3.9.1CAS number 9002-04-4
    D.3.9.3Other descriptive nameHUMAN THROMBIN
    D.3.9.4EV Substance CodeSUB20551
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative air leakage
    Fugas de aire posquirúrgicas
    E.1.1.1Medical condition in easily understood language
    Leak of air after surgery pulmonary resection
    Fuga de aire después de la cirugía de resección pulmonar
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10067826
    E.1.2Term Pulmonary air leakage
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection.
    Comparar la eficacia de Hemopatch con la de TachoSil en la duración de las fugas de aire posquirúrgicas tras la resección pulmonar
    E.2.2Secondary objectives of the trial
    To evaluate the safety of Hemopatch compared to TachoSil in postoperative application after pulmonary resection.
    Comparar la seguridad de Hemopatch con la de TachoSil cuando se aplican tras la resección pulmonar.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Preoperative
    - Patients, 18 years or older at the time of signing the informed consent form (ICF), undergoing elective pulmonary resections (lobectomy, segmentectomy, or wedge resection), either through open thoracotomy or through Video-Assisted Thoracoscopic surgery (VATS).
    - Patients or legally authorized representatives, who are able to give IC after an explanation of the proposed study, and who are willing to comply with the study requirements for therapy during the entire study treatment period.
    - If female of child-bearing potential, patient will present with a negative blood/urine pregnancy test, and will agree to employ adequate birth control measures for the duration of the study.
    Intraoperative
    - Patients with grade 1 or 2 (Macchiarini scale) air leakage after primary stapling and limited suturing.
    Preoperatorios
    - Pacientes que en el momento de la firma del documento del consentimiento informado (DCI) tengan al menos 18 años y vayan a someterse a una resección pulmonar programada (lobulectomía, segmentectomía o resección cuneiforme), bien mediante una toracotomía abierta o cirugía toracoscópica asistida por vídeo (CTAV).
    - Pacientes o sus representantes legalmente autorizados, que puedan otorgar su consentimiento informado, tras explicarles el estudio propuesto, y que estén dispuestos a cumplir los requisitos terapéuticos del estudio durante la totalidad del período de tratamiento de este.
    - En el caso de las mujeres fértiles, deben presentar un resultado negativo en una prueba de embarazo en sangre/orina y estar de acuerdo en utilizar medidas anticonceptivas aceptables durante el estudio.
    Intraoperatorios
    - Pacientes que presenten fugas de aire de grado 1 o 2 (escala de Macchiarini) en la herida, cerrada principalmente con grapas y algunos puntos de sutura.
    E.4Principal exclusion criteria
    Preoperative
    - Patients who had previous lung surgery (on the same side)
    - Patients with an active, florid infection
    - Patients who have received chemotherapy within the previous 3 weeks.
    - Patients who have received radiation therapy within the previous 4 weeks.
    - Patients with known hypersensitivity to the components of the investigational product and control (human fibrinogen, human thrombin, collagen of any origin, NHS-PEG)
    - Patients undergoing emergency surgery
    - Patients on chronic use of steroids
    - Female patients of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period
    - Female patients who are nursing
    - Patients with exposure to another investigational drug or device clinical trial within 30 days prior to enrollment or anticipated in the 30 day study period till the End of study visit.
    - Patient has a clinically significant concurrent medical condition (e.g. concomitant illness, drug/alcohol abuse) that, in the opinion of the investigator, could adversely affect patient’s safety and/or compliance with study procedures
    - Patient is a family member or employee of the investigator
    Intraoperative
    - Patients with serious complications during surgery, including the need for adhesiolysis, and pneumonectomy.
    - Patients who were treated with any surgical sealant
    - Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
    - Patients with any other intraoperative findings identified by the surgeon that may preclude the conduct of the study procedure
    Preoperatorios
    - Pacientes que se hayan sometido a cirugía pulmonar (en el mismo lado).
    - Pacientes con una infección activa y grave.
    - Pacientes que hayan recibido quimioterapia en el transcurso de las tres semanas anteriores.
    - Pacientes que hayan recibido radioterapia en el transcurso de las cuatro semanas anteriores.
    - Pacientes con hipersensibilidad a los componentes del producto en investigación o del producto de referencia (fibrinógeno humano, trombina humana, colágeno de cualquier origen, NHS-PEG).
    - Pacientes que se sometan a una intervención quirúrgica de urgencia.
    - Pacientes en tratamiento prolongado con corticoesteroides.
    - Mujeres fértiles que presenten un resultado positivo en una prueba de embarazo o que deseen quedarse embarazadas durante el estudio clínico.
    - Mujeres en período de lactancia.
    - Pacientes que se hayan expuesto a otro fármaco o producto sanitario en investigación en el ámbito de un ensayo clínico, en el transcurso de los 30 días anteriores a la fecha de reclutamiento, o que se prevea que vayan a exponerse en el período del estudio de 30 días hasta el final de la visita del estudio.
    - Pacientes con una enfermedad o situación concurrente clínicamente importante (por ejemplo, enfermedad concomitante, toxicomanía/consumo excesivo de alcohol) que, en opinión del investigador, podría afectar de forma negativa la seguridad del paciente o su grado de cumplimiento de los procedimientos del estudio.
    - Pacientes que sean familiares o empleados del investigador.
    Intraoperatorios
    - Pacientes con complicaciones graves durante la cirugía, incluidas la necesidad de adherenciotomía y neumonectomía.
    - Pacientes a los que se haya tratado con cualquier sellador quirúrgico.
    - Complicaciones intraoperatorias graves que requieran maniobras de reanimación o desviaciones respecto al procedimiento quirúrgico programado.
    - Pacientes en los que el cirujano identifique cualquier hallazgo intraoperatorio que pueda impedir que se lleve a cabo el procedimiento del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The duration of postoperative air leakage, measured in days.
    La duración de la fuga de aire posquirúrgica, medida en días.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Postoperative air leakage will be assessed on the evening of the day of operation and subsequently at least twice daily (morning and evening) until chest drain removal. All patients will be followed up to 30 days postoperatively.
    Las fugas de aire postoperatorias se evaluarán la noche del día de la operación y posteriormente al menos dos veces al día (mañana y tarde) hasta la extracción del drenaje torácico. Todos los pacientes serán seguidos hasta 30 días después de la operación.
    E.5.2Secondary end point(s)
    - Incidence of intraoperative treatment failure
    - Incidence of patients with prolonged air leakage defined as air leakage > 5 days
    - Evaluation of hemostasis after application of product if bleeding at the surgical site occurs
    - The need for additional procedures (chest drainage, re-operation, respiratory assistance, and blood transfusion)
    - Time to chest tube removal
    - Time in surgery (minutes) from incision to closure
    - Length of stay in hospital (days)
    - Number of unplanned interventions within 30 days postoperatively
    - Incidence of adverse events (AEs) including pre-defined postoperative Adverse Events of Special Interest (AESIs) up to 30 + or - 3 days after surgery:
    1- Pneumothorax
    2- Bronchopleural fistula
    3- Emphysema (subcutaneous and mediastinal)
    4- Pleural effusions
    5- Postoperative respiratory failure
    6- Empyema
    7- Allergic reactions in reasonable temporal relationship with the product application
    - Number of patches used (for both investigational and control devices)
    - Vital signs and laboratory tests
    - Incidencia de fracasos del tratamiento intraoperatorio
    - Incidencia de pacientes con fuga de aire prolongada (esto es, que dure > 5 días)
    - Evaluación de la hemostasia tras la aplicación del producto, en caso de hemorragia en el lecho quirúrgico
    - Necesidad de procedimientos adicionales (drenaje torácico, otra operación, asistencia respiratoria y transfusión de sangre)
    - Tiempo transcurrido hasta la retirada del drenaje torácico
    - Duración (minutos) de la intervención quirúrgica, desde la incisión al cierre
    - Duración (días) de la estancia hospitalaria
    - Número de intervenciones imprevistas en el transcurso de los 30 días posteriores a la intervención quirúrgica
    - Incidencia de acontecimientos adversos (AA), incluidos los acontecimientos adversos posquirúrgicos de interés especial (AAIE) definidos de antemano, en el período de tiempo de hasta 30 ± 3 días después de la cirugía:
    1- Neumotórax
    2- Fístula broncopleural
    3- Enfisema (subcutáneo y mediastínico)
    4- Derrames pleurales
    5- Insuficiencia respiratoria posquirúrgica
    6- Empiema
    7- Reacciones alérgicas con una relación temporal razonable con la aplicación del producto
    - Número de parches utilizados (tanto para el dispositivo en investigación como para el dispositivo de referencia)
    - Constantes vitales y pruebas analíticas
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will be assessed during surgery and up to 30 + or - 3 days after surgery.
    Los criterios de valoración secundarios se evaluarán durante la cirugía y hasta 30 + o - 3 días después 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 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 Yes
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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: 111
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 166
    F.4.2.2In the whole clinical trial 166
    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)
    Standard of care
    Práctica de tratamiento habitual
    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 Decision2018-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-07-09
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