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    Summary
    EudraCT Number:2016-000071-24
    Sponsor's Protocol Code Number:TRANEXTIME
    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:2016-02-03
    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 number2016-000071-24
    A.3Full title of the trial
    TIME OF ADMINISTRATION OF TRANEXAMIC ACID TO PREVENT BLEEDING IN TOTAL KNEE ARTHROPLASTY
    DETERMINAR EL MOMENTO DE ADMINISTRACIÓN DE ÁCIDO TRANEXÁMICO PARA PREVENIR EL SANGRADO EN CIRUGÍA DE PRÓTESIS TOTAL DE RODILLA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Which is the best moment to administer tranexamic acid in total knee arthroplasty to prevent bleeding
    Determinar cuando es mejor administrar el ácido tranexámico en cirugía de protesis de rodilla para prevenir el sangrado
    A.4.1Sponsor's protocol code numberTRANEXTIME
    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 SponsorConsorci Mar Parc de Salut de Barcelona (Parc de Salut MAR)
    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 supportNo
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationServicio de Anestesiología y Reanimación
    B.5.2Functional name of contact pointServicio de Anestesiología
    B.5.3 Address:
    B.5.3.1Street AddressAvinguda del Santuari de Sant Josep de la Muntanya, 12
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08024
    B.5.3.4CountrySpain
    B.5.4Telephone number003493367 41 93
    B.5.5Fax number003493248 36 17
    B.5.6E-mailebisbe@parcdesalutmar.cat
    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 Amchafibrin 500mg solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderROTTAPHARM, S.L.
    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 Solution for injection
    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 INNACIDO TRANEXAMICO
    D.3.9.1CAS number 1197-18-8
    D.3.9.2Current sponsor codeACIDO TRANEXAMICO
    D.3.9.3Other descriptive nameTRANEXAMIC ACID
    D.3.9.4EV Substance CodeSUB11214MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 25
    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
    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
    Total knee arthroplasty bleeding
    Sangrado en cirugía de protesis total de rodilla
    E.1.1.1Medical condition in easily understood language
    Total knee arthroplasty bleeding
    Sangrado en cirugía de protesis total de rodilla
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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
    To demonstrate that tranexamic acid administered 30 minutes before ischemia further reduces free volume of postoperative bleeding in knee replacement (TKR) that administered before the surgical incision.
    Demostrar que el ácido tranexámico administrado 30 minutos antes de liberar la isquemia reduce más el volumen de sangrado postoperatorio en las prótesis de rodilla (PTR) que administrado previo a la incisión quirúrgica.
    E.2.2Secondary objectives of the trial
    a) To assess whether a second additional dose of 10 mg / kg of tranexamic acid helps to reduce the total postoperative bleeding.
    b) To assess the incidence of clinically significant thromboembolic events.
    a) Evaluar si una segunda dosis adicional de ácido tranexámico de 10 mg/kg contribuye a reducir el sangrado postoperatorio total.
    b) Evaluar la incidencia de eventos tromboembólicos clínicamente relevantes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Adult patients of both genre aged between 18 and 85 years.
    - Patients scheduled for primary and unilateral total knee arthroplasty with tourniquet.
    - Patients who signed informed consent indicating that they have been informed of all pertinent aspects of the trial.
    -Pacientes adultos de ambos sexos de edades comprendidas entre los 18 y 85 años.
    -Pacientes programados de cirugía de prótesis total de rodilla primaria y unilateral con isquemia durante la intervención.
    -Pacientes que firmen el consentimiento informado indicando que han sido informados de todos los aspectos pertinentes sobre el ensayo.
    E.4Principal exclusion criteria
    -Pregnancy or risk of pregnancy ( fertile women who do not take contraceptives) or lactating.
    - Participation in a clinical drug research before 3 months in pre-drug administration.
    - Congenital or acquired bleeding disorder including thrombophilia.
    - Absolute or relative contraindications of tranexamic acid administration :
    - venous or arterial thrombosis
    - pulmonary thromboembolism
    - paroxysmal atrial fibrillation
    - chronic kidney failure with GFR <40mm
    - epilepsy (seizures in the last year)
    -Embarazo o riesgo de embarazo (mujeres fértiles que no tomen anticonceptivos) o en periodo de lactancia
    -Participación en alguna investigación clínica con medicamentos dentro de los 3 meses anteriores a la administración del fármaco.
    -Alergia o hipersensibilidad a Amchafibrin o a alguno de los excipientes del medicamento en estudio
    -Trastorno adquirido o congénito de la coagulación incluyendo la trombofilia
    -Contraindicación absoluta o relativa a la administración de ácido tranexámico:
    -Antecedente de trombosis arterial o venosa
    -Antecedente de tromboembolismo pulmonar
    -Fibrilación auricular paroxística
    - Enfermedad renal crónica con TFG<40mm
    - Antecedente de epilepsia (convulsiones en el último año)
    E.5 End points
    E.5.1Primary end point(s)
    Perioperative bleeding in milliliters ( ml ) .
    -Visible Losses : Total amount of bleeding in the draw ( until his retirement )
    -Total estimated blood loss : according to formula described in the protocol.
    Es el sangrado perioperatorio en militros (ml).
    -Pérdidas visibles: Cantidad total de sangrado en el drenaje (hasta su retirada)
    -Pérdidas sanguínea total calculada: segun formúla descrita en el protocolo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Bleeding from surgery day untill 4th day.
    Sangrado desde la cirugía hasta el cuarto día
    E.5.2Secondary end point(s)
    -Adverse events related to treatment with antifibrinolytic : venous thrombosis, pulmonary embolism, arterial thrombosis, acute myocardial infarction , transient ischemic attack , cerebral vascular accident etc.
    -Units of packed red blood cells transfused and patients transfused
    -Total tranexamic acid (TXM) dose received
    -Efectos adversos relacionados con el tratamiento con antifibrinolítico: trombosis venosa, Tromboembolismo pulmonar (TEP), trombosis arterial (infarto agudo de miocardio (IAM), Accidente isquémico transitorio (TIA), Accidente vascular cerebral (AVC) etc.)
    -Unidades de concentrados de hematíes trasfundidos y pacientes trasfundidos
    -Dosis total de ácido tranexámico recibido
    E.5.2.1Timepoint(s) of evaluation of this end point
    From first acid tranexamic dose untill +/-30 th day post surgery.
    Desde la administración de la primera dosis de ácido tranexámico en la cirugía hasta el día +/-30 del postoperatorio.
    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 Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 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
    Last visit of the last recruited patient.
    Última visita del último paciente reclutado.
    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 months2
    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: 32
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 160
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state192
    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)
    Patients will receive adequate treatment by their physician.
    Los pacientes recibirán el tratamiento que su médico considere oportuno.
    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 Decision2016-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-12
    P. End of Trial
    P.End of Trial StatusOngoing
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