Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2022-003163-21
    Sponsor's Protocol Code Number:COTHUGMTRA22
    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:2023-03-24
    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 number2022-003163-21
    A.3Full title of the trial
    PHASE III, SINGLE-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, LOW-INTERVENTION CLINICAL TRIAL IN TWO PARALLEL GROUPS, TO EVALUATE EFFICACY AND SAFETY IN ELDERLY PATIENTS WITH PERTROCHANTERIC FRACTURE, RECEIVING TREATMENT WITH TRANEXAMIC ACID IV VS. IV+LOCAL IN THE SURGICAL BED.
    ENSAYO CLÍNICO DE BAJO NIVEL DE INTERVENCIÓN FASE III, UNICÉNTRICO, DOBLE CIEGO, ALEATORIZADO, CONTROLADO (CON PLACEBO) EN DOS GRUPOS PARALELOS, PARA EVALUAR LA EFICACIA Y SEGURIDAD EN PACIENTES ANCIANOS CON FRACTURA PERTROCANTÉREA, QUE RECIBEN TRATAMIENTO CON ÁCIDO TRANEXÁMICO IV VS IV+LOCAL EN LECHO QUIRÚRGICO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY IN ELDERLY PATIENTS WITH PERTROCHANTERIC FRACTURE, RECEIVING TREATMENT WITH TRANEXAMIC ACID IV VS IV+LOCAL IN THE SURGICAL BED.
    ENSAYO CLÍNICO PARA EVALUAR LA EFICACIA Y SEGURIDAD EN PACIENTES ANCIANOS CON FRACTURA PERTROCANTÉREA, QUE RECIBEN TRATAMIENTO CON ÁCIDO TRANEXÁMICO IV VS IV+LOCAL EN LECHO QUIRÚRGICO
    A.4.1Sponsor's protocol code numberCOTHUGMTRA22
    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 SponsorCoral Sánchez Pérez
    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 supportCoral Sanchez
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJaime Flores
    B.5.2Functional name of contact pointJaime Flores
    B.5.3 Address:
    B.5.3.1Street Addressdoctor esquerdo, 46
    B.5.3.2Town/ citymadrid
    B.5.3.3Post code28007
    B.5.3.4CountrySpain
    B.5.4Telephone number34636476353
    B.5.6E-mailjaime.095@hotmail.com
    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 farma 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 IMPLocal 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 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 placeboLocal use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    pertrochanteric hip fracture
    fractura pertrocantéreas de cadera
    E.1.1.1Medical condition in easily understood language
    pertrochanteric hip fracture
    fractura pertrocantéreas de cadera
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level PT
    E.1.2Classification code 10020100
    E.1.2Term Hip fracture
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    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 the reduction of blood loss with the use of local tranexamic combined with intravenous tranexamic acid
    Demostrar la reducción de pérdida sanguínea con el uso de tranexámico local combinado con intravenoso.
    E.2.2Secondary objectives of the trial
    - To corroborate the safety of the local use of tranexamic acid in pertrochanteric hip fractures.
    - To evaluate differences in the length of hospital stay.
    - corroborate la seguridad del empleo local de tranexámico en fractura pertrocantérea de cadera.
    - evaluar las diferencias en la duración de la estancia hospitalaria.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with pertrochanteric hip fracture admitted to the Gregorio Marañon Hospital during the study period.
    Signed written informed consent form.
    Men and women aged 65 years or older.
    Pacientes con fractura pertrocantérea de cadera, que ingresen el hospital Gregorio Marañon en el periodo del estudio.
    Firma del consentimiento informado escrito
    Hombres y mujeres con una edad de 65 o mas años.
    E.4Principal exclusion criteria
    Fractures of pathological origin (tumor) and those due to polytrauma (2 or more concomitant fractures due to high-energy trauma) and patients with a previous habitual consumption of anticoagulants or antiplatelet drugs will be excluded. The latter will only be excluded from the preelimination analysis to avoid bias, but will be randomized and taken into account at a later stage.
    The presence in the anamnesis of all the conditions that are a contraindication for the use of the drug, as listed in the drug's technical data sheet, will be considered exclusion criteria:
    Acute arterial or venous thrombosis.
    Fibrinolytic diseases after consumption coagulopathy, except in those with predominant activation of the fibrinolytic system with severe acute bleeding.
    Severe renal insufficiency (risk of accumulation).
    History of seizures.
    Analytical data and data obtained in the physical examination.
    Hypersensitivity to any component of the study drug formulation.
    Any other clinical condition or previous therapy that, in the opinion of the investigator, would make the patient ineligible to participate in the study or unable to comply with the dosing requirements.
    Prisoners or persons who are compulsorily detained (involuntary confinement) for the treatment of a psychiatric or physical illness (e.g., an infectious disease) are not eligible to participate in this study.
    se excluirán fracturas de origen patológico (tumorales) y aquellas debidas de politraumatismo (2 o mas fracturas concomitantes por ttraumatismos de alta energia) y pacientes que efectúen un consumo previo habitual de anticoagulantes o antiagregantes. A estos últimos sólo se les excluirá del analisis preeliminar para evitar sesgos, pero sí se aleatorizarán y se tendrán en cuenta mas adelante.
    Se consideraran criterios de exclusión la presencia en la anamnesis de todas las condiciones que suponen una contraindicacion para el empleo del fármaco, recogidas en la ficha técnica del mismo:
    Trombosis aguda arterial o venosa
    Enfermedades fibrinolíticas después de coagulopatía de consumo, excepto en aquellos con activación predominante del sistema fibrinolítico con hemorragia aguda grave.
    Insuficiencia renal grave (riesgo de acumulación).
    Antecedentes de convulsiones.
    No se contempla la exclusión por criterios analiticos previos al empleo del fármaco. En pacientes con insuficiencia renal, se procederá a realizar ajuste de la dosis en función de las cifras de creatinina sérica.
    Hipersensibilidad a cualquier componente de la formulación del fármaco del estudio.
    Cualquier otra afección clínica o terapia previa que, en opinión del investigador, haría que el enfermo no fuese apto para participar en el estudio o no pudiera cumplir con los requisitos de posología.
    No podrán participar en este estudio los presos o las personas que estén obligatoriamente retenidas (reclusión involuntaria) para el tratamiento de una enfermedad psiquiátrica o física (por ejemplo una enfermedad infecciosa).
    E.5 End points
    E.5.1Primary end point(s)
    reduction of blood loss with the use of local tranexamic combined with intravenous tranexamic acid
    reducción de pérdida sanguínea con el uso de tranexámico local combinado con intravenoso.
    E.5.1.1Timepoint(s) of evaluation of this end point
    analytical control the day after surgery
    control analítico al día siguiente de la intervención
    E.5.2Secondary end point(s)
    safety of the local use of tranexamic acid in pertrochanteric hip fractures.
    differences in the length of hospital stay.
    seguridad del empleo local de tranexámico en fractura pertrocantérea de cadera.
    diferencias en la duración de la estancia hospitalaria.
    E.5.2.1Timepoint(s) of evaluation of this end point
    safety: postoperative period, 4-6 weeks and 6 months after surgery
    Hospital Stay: discharge
    seguridad : postoperatorio, 4-6 semanas y 6 meses tras la cirugia
    estancia hospitalaria: al alta
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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
    LPLV
    ultima visita del último 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 months
    E.8.9.1In the Member State concerned days
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 102
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    patients with conditions like dementia and other are allowed.
    se permite la inclusión de pacientes con patologías que afecten a su capacidad para consentir como demencias
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state102
    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)
    NONE
    NINGUNO
    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 Decision2023-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon May 26 01:44:01 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA