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    Summary
    EudraCT Number:2017-002480-17
    Sponsor's Protocol Code Number:FPS-TRA-2017-02
    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:2017-07-12
    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 number2017-002480-17
    A.3Full title of the trial
    Randomized, placebo-controlled, double-blind trial to evaluate the efficacy and safety of topical application of tranexamic acid for saving blood losses in patients subjected to prosthetic knee surgery.
    Ensayo clínico aleatorizado, controlado con placebo y doble ciego para evaluar la eficacia y seguridad del ácido tranexámico tópico en ahorro de pérdidas sanguíneas en pacientes sometidos a cirugía protésica de rodilla.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, placebo-controlled, double-blind trial to evaluate the efficacy and safety of topical application of tranexamic acid for saving blood losses in patients subjected to prosthetic knee surgery.
    Ensayo clínico aleatorizado, controlado con placebo y doble ciego para evaluar la eficacia y seguridad del ácido tranexámico tópico en ahorro de pérdidas sanguíneas en pacientes sometidos a cirugía protésica de rodilla.
    A.4.1Sponsor's protocol code numberFPS-TRA-2017-02
    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 SponsorFundación Pública Andaluza Progreso y Salud
    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 supportFundación Pública Andaluza Progreso y Salud
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Pública Andaluza Progreso y Salud
    B.5.2Functional name of contact pointMarta Reboredo Ares
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Américo Vespucio Nº15 Edificio S-2
    B.5.3.2Town/ citySevilla
    B.5.3.3Post code41092
    B.5.3.4CountrySpain
    B.5.4Telephone number0034955040450
    B.5.5Fax number0034955040457
    B.5.6E-mailgestionensayosclinicos.fps@juntadeandalucia.es
    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
    D.2.1.1.2Name of the Marketing Authorisation holderMeda Pharma SL
    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.3.1Product nametranexamic acid
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtranexamic acid
    D.3.9.3Other descriptive nameTRANEXAMIC ACID
    D.3.9.4EV Substance CodeSUB11214MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 infusion
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Knee arthrosis
    Artrosis de rodilla
    E.1.1.1Medical condition in easily understood language
    Knee arthrosis
    Artrosis de rodilla
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    The aim objective is to compare the efficacy and safety of topical tranexamic acid versus placebo in patients diagnosed of severe knee osteoarthritis in total primary knee prosthesis, in blood loss decrease (estimated blood loss, low hemoglobin, low hematocrit), and to assess the safety profile of topical tranexamic acid in patients subjected to prosthetic knee surgery.
    Comparar la eficacia y seguridad del acido tranexámico tópico con respecto a placebo en pacientes diagnosticados de artrosis de rodilla severa que van a ser sometidos a cirugía protésica de rodilla primaria, en términos de ahorro de pérdidas sanguíneas (pérdida de sangre estimada, disminución de hemoglobina y disminución de hematocrito).
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy and safety of topical tranexamic acid versus placebo in patients diagnosed for severe knee osteoarthritis in total primary knee prosthesis to determine the need of red blood cells transfusion.

    - To evaluate the functional recovery time in patients treated with topical tranexamic acid with respect to placebo.

    - To evaluate different indicators of hospital use as the length of hospital stay.
    • Evaluar comparativamente la eficacia y seguridad de ácido tranexámico tópico con respecto a placebo en pacientes diagnosticados de artrosis de rodilla severa en prótesis total de rodilla primaria, en términos de necesidad de transfusión de concentrados de hematíes.
    • Evaluar el tiempo de recuperación funcional en pacientes tratados con ácido tranexámico tópico con respecto a placebo.
    • Evaluar distintos indicadores de utilización hospitalaria, como puede ser el tiempo de estancia hospitalaria.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients of both sexes, in the age group: ≥18 and ≤80 years.

    • Patients diagnosed with confirmation of severe knee osteoarthritis according to Kellgren criteria (equal or greater than 2) and EVA greater than 7, who will be sujected to knee arthroplasty surgery.

    • Patients signing informed consent, agreeing to participate in the study.
    • Pacientes de ambos sexos, pertenecientes al grupo de edad: ≥18 y ≤80 años.
    • Pacientes con diagnóstico de confirmación de artrosis severa de rodilla según los criterios de Kellgren (igual o mayor de 2) y EVA mayor de 7, que van a ser sometidos a cirugía artroplástica de rodilla.
    • Pacientes que firmen el consentimiento informado, aceptando participar en el estudio.
    E.4Principal exclusion criteria
    • Patients with concomitant cardiac disease: unstable angina pectoris, acute myocardial infarction, atrial fibrillation, flutter, history of sudden death, severe valve insufficiency.
    • Patients with concomitant previous thromboembolic disease: Deep venous thrombosis, pulmonary thromboembolism, thrombotic arterial embolism, Ischemic Vascular Cerebral Stroke, fibrinolytic diseases after coagulopathy consumption.
    • Hypersensitivity to tranexamic acid.
    • Severe systemic disease: cardio-pulmonary, neurological, renal, infectious or any other type that may impede the development of the study or evaluation of the results.
    • History of seizures.
    • Patients with severe mental disorder (psychotic disorder, risk of autolysis, manic episode), dependence on toxic substances and / or some physical or psychological limitation to answer.
    • Patients receiving oral anticoagulants.
    • Patients in litigation for disability claim related or not with the disease.
    • Patients who cannot make the necessary visits to carry out the study.
    • Patients who refuse to participate or sign informed consent.
    • Pregnant and lactating patient’s period.
    • Pacientes con patología cardiaca concomitante: angina de pecho inestable, infarto agudo de miocardio, fibrilación auricular, flutter, antecedentes de muerte súbita, insuficiencia valvular severa.
    • Pacientes con enfermedad tromboembólica previa concomitante: Trombosis venosa profunda, tromboembolismo pulmonar, embolismo arterial de características trombóticas, Accidente Cerebral Vascular Isquémico, enfermedades fibrinolíticas después de coagulopatía de consumo.
    • Hipersensibilidad al ácido tranexámico.
    • Enfermedad sistémica grave: cardio-pulmonar, neurológica, renal, infecciosa o de cualquier otro tipo que pueda impedir el desarrollo del estudio o evaluación de los resultados.
    • Antecedentes de convulsiones.
    • Pacientes con trastorno mental grave (trastorno psicótico, riesgo de autolisis, episodio maniaco), dependencia de sustancias toxicas y/o alguna limitación física o psíquica para contestar.
    • Pacientes en tratamiento con anticoagulantes orales.
    • Pacientes en litigio por reclamación de invalidez relacionado o no con la enfermedad.
    • Pacientes que no puedan acudir a las visitas necesarias para llevar a cabo el estudio.
    • Pacientes que se nieguen a participar o a firmar el consentimiento informado.
    • Pacientes embarazadas y pacientes en periodo de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in estimated blood loss greater than or equal to 245 ml.
    Diferencia en la pérdida sanguínea estimada mayor o igual de 245 ml
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hour
    24 horas
    E.5.2Secondary end point(s)
    24 hour
    24 horas
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 hour
    24 horas
    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) 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 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 trial2
    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
    NA
    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 months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state150
    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)
    Clinical practice
    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 Decision2017-11-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-08
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