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    Summary
    EudraCT Number:2011-003218-17
    Sponsor's Protocol Code Number:TRANEX1
    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:2011-07-12
    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 number2011-003218-17
    A.3Full title of the trial
    Efficacy of topical tranexamic acid versus intravenous administration to reduce blood transfussion rate in total knee arthroplasty surgery: phase III, unicentric, controlled,double blind, randomized non inferiority clinical trial.
    Eficacia del ácido tranexámico de administración tópica frente a la administración IV para disminuir la tasa de transfusión sanguínea en cirugía de artroplastia total de rodilla: Estudio clínico aleatorizado, doble ciego, con criterio de no inferioridad
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy comparation of topical tranexamic acid versus intravenous tranexamic acid to reduce the number of blood transfussions in knee surgery
    Evaluación de la eficacia del ácido tranexamico administrado vía tópica en comparación con el ácido tranexamico administrado vía IV
    A.3.2Name or abbreviated title of the trial where available
    TRANEX1
    A.4.1Sponsor's protocol code numberTRANEX1
    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 SponsorHospital Universitario La Paz
    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 supportHospital Universitario La Paz
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario La Paz
    B.5.2Functional name of contact pointInvestigador Principal
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la castellana, No. 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number34917277085
    B.5.5Fax number34914269774
    B.5.6E-mailnorma.padilla@uam.es
    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 AMCHAFIBRIN
    D.2.1.1.2Name of the Marketing Authorisation holderAMCHAFIBRIN
    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 nameAMCHAFIBRIN
    D.3.2Product code B02AA02
    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 INNÁcido Tranexamico
    D.3.9.1CAS number 1197-18-8
    D.3.9.2Current sponsor codeTRANEX1
    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 typeequal
    D.3.10.3Concentration number15
    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.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 AMCHAFIBRIN
    D.2.1.1.2Name of the Marketing Authorisation holderAMCHAFIBRIN
    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 nameAMCHAFIBRIN
    D.3.2Product code B02AA02
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPLocal use (Noncurrent)
    Intraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNÁcido Tranexamico
    D.3.9.1CAS number 1197-18-8
    D.3.9.2Current sponsor codeTRANEX1
    D.3.9.3Other descriptive nameTRANEXAMIC ACID
    D.3.9.4EV Substance CodeSUB11214MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    El sangrado perioperatorio es común en intervenciones quirúrgicas de ortopedia, especialmente en los reemplazos de rodilla con una estimación media de transfusión de concentrados de hematíes de un 40%. El ácido tranexámico por vía sistémica ha sido utilizado para disminuir las pérdidas de sangre en cirugía ortopédica y existe un precdente que indica que la administración tópica puede ser eficaz.
    E.1.1.1Medical condition in easily understood language
    La ortoplastia total de rodilla es una cirugía en donde el 40% de los pacientes requieren transfusión sanguínea. Para disminuir la necesidad de transfusión se administras ácido tranexámico.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10033380
    E.1.2Term Pain back
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10052438
    E.1.2Term Paranasal sinus discomfort
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10040562
    E.1.2Term Shock anaphylactic anaphylactoid
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10047700
    E.1.2Term Vomiting
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10028813
    E.1.2Term Nausea
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10066331
    E.1.2Term Arterial hypotension
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10047514
    E.1.2Term Vision central defective
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10051385
    E.1.2Term Drug-induced headache
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10043566
    E.1.2Term Thromboembolism
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level HLGT
    E.1.2Classification code 10047518
    E.1.2Term Vision disorders
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10027606
    E.1.2Term Migraine type headaches
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar con criterio de no inferioridad la eficacia y seguridad del ácido tranexámico de administración tópica frente a la administración por vía intravenosa, para mantener baja la tasa de transfusión sanguínea en cirugía primaria de artroplastia total de rodilla
    E.2.2Secondary objectives of the trial
    -Determinar en cada grupo la diferencia de sangrado visible a las 24horas.
    -Estimar en ambos grupos la pérdida de sangre no visible mediante Hb/Htc seriados en la unidad de reanimación post quirúrgica (URPA), a las 24 horas, a las 48 horas y los 5 días de estancia hospitalaria.
    -Determinar la presencia de eventos adversos durante la estancia hospitalaria.
    -Determinar las características sociodemográficas y las características de riesgo de ambos grupos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Mayores de 18 años de ambos sexos
    2)Propuesto para cirugía primaria o secundaria de artroplastia total de rodilla
    3)Pacientes de el Hospital Cantoblanco-La Paz, Madrid, España
    E.4Principal exclusion criteria
    1)Ausencia de consentimiento informado por escrito
    2)Alergia/contraindicación al ácido tranexámico
    3)Comorbilidades mayores como: cardiopatía isquémica severa (clase III y IV de la New Cork Herat Association), síndrome de apnea del sueño, EPOC severo, disfunción renal (creatinina plasmática >2mg/dL en hombres y >1.8mg/dL en mujeres) o disfunción hepática
    4)Coagulopatía identificada en el preoperatorio por recuento plaquetar <150.000/mm3, razón internacional normalizada (INR) >1.4, o tiempo parcial de tromboplastina (TTPa) prolongado (>1.4 veces la normal)
    5)Antecedentes de enfermedad troboembólica arterial o venosa como: accidente cerebrovascular, trombosis venosa profunda, tromboembolia pulmonar
    6)Discrasias sanguíneas hematopoyéticas, hemorrágicas y trombogénicas
    7)Retinopatía (limitación del campo visual y distorsión en la percepción del color)
    8)Religión: Testigos de Jehová (existe un protocolo especifico para estos casos)
    9)Embarazo
    10)Lactancia
    11)Estar participando en otro estudio clínico o haber participado en uno hace menos de un año
    E.5 End points
    E.5.1Primary end point(s)
    Número de transfusiones realizadas en cada grupo como proporción del total de transfusiones realizadas en el estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    postoperatorio
    E.5.2Secondary end point(s)
    -Medición en mililitros de la pérdida de sangre visible (drenaje Drenofast) en cada grupo 24 horas después de la cirugía
    -Estimación en mililitros de la pérdida de sangre no visible en cada grupo en la unidad de reanimación post quirúrgica (URPA) a las 3 horas, a las 24 horas, a las 48 horas y a los 5 días después de la cirugía.
    -Determinación de posibles eventos adversos relacionados con el medicamento estudiado durante la participación en el estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pérdida visible de sangre: Cantidad en mL de sangre recolectada en el drenaje 24 horas después de la cirugía, por grupo
    Pérdida invisible de sangre: Estimación de pérdida de sangre en mL (a las 3 horas, a las 24 horas, a las 48 horas y a los 5 días), por grupo, empleando la fórmula de Nedler:
    Pérdida de sangre(mL)= 75 x Peso(Kg) x [(Hb0-Hb1)/Hb0]+Transfusión sanguínea(mL)
    -Eventos adversos: postoperatorio por apreciación clínica
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Evaluación de no inferioridad
    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 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 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
    El estudio termina con el alta hospitalaría del 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 months0
    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 months0
    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 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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state78
    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)
    No se dará tratamiento especial a los sujetos una vez concluída su participación en el estudio. Como parte del tretamiento convencinoal los pacientes sometidos a una cirugía de artroplastia de rodilla serán citados a curación a las dos semanas post-intervención quirúrgica y a las seis semanas para control por su traumatólogo.
    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 Decision2012-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
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