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    Summary
    EudraCT Number:2011-003669-14
    Sponsor's Protocol Code Number:ISRCTN15088122
    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:2012-06-12
    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 number2011-003669-14
    A.3Full title of the trial
    Tranexamic Acid for the treatment of significant traumatic brain injury: an international, randomised, double blind, placebo controlled trial.
    Ácido tranexámico para el tratamiento de un trauma craneano
    significativo: un estudio internacional, aleatorizado, doble ciego y
    controlado con placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tranexamic Acid for the treatment of significant traumatic head injury - CRASH-3
    Ácido tranexámico para el tratamiento de un traumatismo grave en el cráneo
    A.3.2Name or abbreviated title of the trial where available
    CRASH-3 [Version 1.0]
    CRASH-3 [Version 1.0]
    A.4.1Sponsor's protocol code numberISRCTN15088122
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN15088122
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01402882
    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 SponsorLondon School Of Hygiene and Tropical Medicine
    B.1.3.4CountryUnited Kingdom
    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 supportJP Moulton Charitable Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLondon School Of Hygiene and Tropical Medicine
    B.5.2Functional name of contact pointHaleema Shakur
    B.5.3 Address:
    B.5.3.1Street AddressKeppel Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1E 7HT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00442079588113
    B.5.5Fax number00442072994663
    B.5.6E-mailhaleema.shakur@lshtm.ac.uk
    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 Cyklokapron
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameCyklokapron
    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 INNTranexamic Acid
    D.3.9.1CAS number 1197-18-8
    D.3.9.2Current sponsor codeISRCTN15088122
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Traumatic Brain Injury
    Traumatismo craneal
    E.1.1.1Medical condition in easily understood language
    Damage to the brain caused by a sudden external force
    Daño cerebral causado por una fuerza externa repentina
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10060690
    E.1.2Term Traumatic brain injury
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The CRASH-3 trial will see if a drug called tranexamic acid will improve outcomes for people who have suffered a traumatic head injury. The main outcome is its effect on death within 28 days of the head injury. We will also assess the cause of death.
    El estudio CRASH-3 va a comprobar si un fármaco denominado ácido tranexámico mejora la evolución de pacientes que han sufrido un traumatismo cerebral. La variable objetivo primaria es la mortalidad a los 28 días. Se valorará también la causa de la muerte.
    E.2.2Secondary objectives of the trial
    The secondary objectives will be to assess whether using tranexamic acid leads to better outcomes such as reduced disability, fewer days in intensive care, and fewer surgical interventions. In addition, we will assess whether there is any increase in serious outcomes including heart attack, stroke and blood clots in the legs or lungs, and seizures.
    Los objetivos secundarios incluyen la valoración del efecto del ácido tranexámico en otras variables como reducción de la discapacidad, menor número de días en cuidados intensivos, y un menor número de intervenciones quirúrgicas. Además, vamos a evaluar si hay algún aumento en los resultados graves, incluyendo infarto de miocardio, accidente cerebrovascular y coágulos sanguíneos en las piernas o los pulmones, y convulsiones.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult (16 years and older) with traumatic brain injury (TBI)
    ? who are within 8 hours of injury
    ? with any intracranial bleeding on CT scan OR GCS ?12 if no scan available, and
    ? who have no significant extra cranial bleeding (needing immediate blood transfusion)
    ? The fundamental eligibility criterion is the responsible clinician?s ?uncertainty? as to whether or not to use tranexamic acid in a particular patient with TBI
    Adultos (16 años o mayores) con traumatismo craneoencefálico (TCE):
    -que se hayan lesionado no más de ocho horas antes
    - con cualquier sangrado intracraneano en una tomografía computarizada o que tengan una ECG de 12
    o menos y
    - que tienen sangrado extracraneal no significativo (con necesidad de transfusión de sangre inmediata)
    - El criterio fundamental de elegibilidad es la ?incertidumbre? del médico responsable acerca de si usar o no
    usar ácido tranexámico en un paciente en particular con un trauma craneano
    E.4Principal exclusion criteria
    ? Patients should not be randomised if the responsible clinician considers there is a clear indication for antifibrinolytic therapy
    ? Patients should not be randomised if the responsible clinician considers there is a clear contraindication for antifibrinolytic therapy
    Los pacientes no se deben aleatorizar si el médico responsable considere que existe una clara indicación para el tratamiento antifibrinolítico.
    Los pacientes no se deben aleatorizar si el médico responsable considere que existe una clara contraindicación para el tratamiento antifibrinolítico.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is death in hospital within 28 days of injury. Cause-specific mortality will also be recorded.
    La medida de resultado primario es la muerte en el hospital dentro de los 28 días de la lesión. También se valorará la causa de la muerte.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after randomisation or at death or hospital discharge if either happens sooner
    28 días después de la aleatorización o muerte o alta del hospital, lo que ocurra antes
    E.5.2Secondary end point(s)
    (a)Vascular occlusive events (myocardial infarction, pulmonary embolism, clinical evidence of deep vein thrombosis)
    (b)Stroke
    (c)Disability assessed using the Disability Rating Scale and Patient Orientated Outcome measures
    (d)Seizures
    (e)Neurosurgical intervention
    (f)Days in intensive care
    (g)Other adverse events
    (a) eventos oclusivos vasculares (infarto de miocardio, embolia pulmonar, evidencia clínica de trombosis venosa profunda)
    (b) AVC

    Discapacidad valorada usando la Escala de calificación de discapacidad y las medidas de Desenlaces
    orientados al paciente
    (d) Convulsiones
    (e) Intervención neuroquirúrgica
    (f) Días en cuidados intensivos
    (g) Se describirán otros eventos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days after randomisation or at death or hospital discharge if either happens sooner
    28 días después de la aleatorización o muerte o alta del hospital, lo que ocurra antes
    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 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 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Albania
    Argentina
    Bangladesh
    Cameroon
    Colombia
    Ecuador
    Egypt
    El Salvador
    Georgia
    Ghana
    India
    Indonesia
    Jamaica
    Kenya
    Mexico
    Nigeria
    Pakistan
    Spain
    Sudan
    Thailand
    Tunisia
    Uganda
    Ukraine
    United Kingdom
    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
    After 10,000 patients have been recruited (anticipated to be completed by 31st December, 2016), the trial will end when follow up (max 28 days) of the last patient recruited is completed.

    The trial may be terminated early by the Trial Steering Committee on the recommendation of the Independent Data Monitoring Committee on their interim reviews of the unblinded data.
    Tras la inclusión de 10.000 pacientes (proyectada para el 31 de Diciembre, 2016), el proceso terminará cuando el seguimiento (máximo 28 días) del último paciente reclutado se haya completado.

    El estudio puede ser parado de forma anticipada por recomendación del Comité Independiente de Supervisión de datos en sus revisiones no ciegas planificadas como análisis intermedio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 1000
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1000
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 8000
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1000
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-06-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients eligible have sustained a traumatic brain injury and have either intracranial bleeding on a CT scan or a GCS of 12 or less. Treatments to improve outcomes must be given as soon as possible in the critical emergency
    Los pacientes elegibles han sufrido una lesión cerebral traumática / hemorragia intracraneal en TC o un GCS<12. Los tratamientos para mejorar los resultados se deben dar tan pronto como sea posible en la situación de emergencia crítica
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 10000
    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)
    After a loading dose is given, a maintenance dose is given over 8 hours

    There is no need for continued provision of the intervention after the maintenance dose as the trial is looking at the effects of early administration of tranexamic acid on traumatic brain injury

    All patients will receive standard care as per the hospital's clinical guidelines for TBI treatment both during and after their participation in the trial
    Después de una dosis de carga, se administra una dosis de mantenimiento durante 8 horas.

    No hay necesidad de suministro continuo después de la dosis de mantenimiento ya que el estudio se centra en en los efectos de la administración temprana de ácido tranexámico en la lesión cerebral traumática

    Todos los pacientes recibirán la atención estándar de acuerdo con los protocolos clínicos de manejo habitual del paciente con TCE, durante y después de su participación en el ensayo
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-12-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-03
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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