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    Summary
    EudraCT Number:2011-006278-15
    Sponsor's Protocol Code Number:IIBSP-FAT-2011-103
    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:2012-02-28
    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 number2011-006278-15
    A.3Full title of the trial
    Prevention of postoperative bleeding: A multicenter, randomized, parallel, controlled clinical trial, evaluating the efficacy of tranexamic acid and fibrin glue in patients undergoing interventions for sub-capital femoral fracture.
    Prevencion del sangrado postoperatorio: Ensayo clinico, multicéntrico, aleatorizado, controlado, paralelo, que evalua la eficacia del ácido tranexámico y la cola de fibrina fracturas subcapitales de femur.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of postoperative bleeding: A multicenter, randomized, parallel, controlled clinical trial, evaluating the efficacy of tranexamic acid and fibrin glue in patients undergoing interventions for sub-capital femoral fracture.
    Prevencion del sangrado postoperatorio: Ensayo clinico, multicéntrico, aleatorizado, controlado, paralelo, que evalua la eficacia del ácido tranexámico y la cola de fibrina fracturas subcapitales de femur.
    A.4.1Sponsor's protocol code numberIIBSP-FAT-2011-103
    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 SponsorInstitut de Recerca Hospital de la Sant Creu i Sant Pau
    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 supportNational Health Authorities
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca Hospital de la Santa Creu i Sant Pau
    B.5.2Functional name of contact pointRomy Rodríguez
    B.5.3 Address:
    B.5.3.1Street AddressC. Sant antoni Maria Claret, 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number00349329190001969
    B.5.5Fax number0034935537812
    B.5.6E-mailRRodriguezMu@santpau.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
    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/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Epilesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1197-18-8
    D.3.9.3Other descriptive nameTRANEXAMIC ACID
    D.3.9.4EV Substance CodeSUB11214MIG
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Evicel
    D.2.1.1.2Name of the Marketing Authorisation holderOmrix Biopharmaceuticals S.A.
    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 sealant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Epilesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 9001-32-5
    D.3.9.3Other descriptive nameHUMAN FIBRINOGEN
    D.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.50 to 0.90
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 04/04/9002
    D.3.9.3Other descriptive nameHUMAN THROMBIN
    D.3.9.4EV Substance CodeSUB20551
    D.3.10 Strength
    D.3.10.1Concentration unit AU/ml allergy unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number800 to 1200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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: 3
    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 Cola Fibrina BST
    D.2.1.1.2Name of the Marketing Authorisation holderBanc de Sang i Teixits
    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 namecola de fibrina del BSTC
    D.3.2Product code cola de fibrina del BSTC
    D.3.4Pharmaceutical form Solution for sealant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    Epilesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 9001-32-5
    D.3.9.3Other descriptive nameHUMAN FIBRINOGEN
    D.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.13 to 0.37
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 04/04/9002
    D.3.9.3Other descriptive nameHUMAN THROMBIN
    D.3.9.4EV Substance CodeSUB20551
    D.3.10 Strength
    D.3.10.1Concentration unit AU/ml allergy unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 47
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patient with a hip fracture and a prosthesis is needed.
    Paciente con fractura de cadera y necesita una prótesis.
    E.1.1.1Medical condition in easily understood language
    Patient with a hip fracture and a prosthesis is needed.
    Paciente con fractura de cadera y necesita una prótesis.
    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
    To assess whether tranexamic acid or fibrin glue administered topically reduce by at least 25% blood loss with respect to control in patients undergoing subcapital fracture of the femur.
    Evaluar si el ácido tranexámico o la cola de fibrina administrados vía tópica reducen al menos en un 25% la pérdida sanguínea con respecto al control en pacientes intervenidos de fractura subcapital de fémur.
    E.2.2Secondary objectives of the trial
    1. Hidden blood loss calculated from the formula of Nadler (1962).
    2. Proportion of patients requiring blood transfusion in the postoperative
    3. Preoperative and postoperative hemoglobin
    4. Number. of blood transfusions
    5. Units of blood transfusions administered
    6. Incidence of wound infection
    7. Pain patient's surgical wound
    8. Days in hospital
    9. Related side effects
    1. Pérdida de sangre oculta calculada a partir de la fórmula de Nadler (1962).
    2. Proporción de pacientes que necesitan transfusión sanguínea en el postoperatorio
    3. Hemoglobina pre y postoperatoria
    4. Nº de transfusiones sanguíneas
    5. Unidades de transfusiones sanguíneas administradas
    6. Incidencia de infección de la herida
    7. Dolor de la herida quirúrgica del paciente
    8. Días de estancia hospitalaria
    9. Efectos secundarios relacionados con las
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients older than 18 years
    -Patients with unilateral subcapital femoral fracture
    -Patients requiring hip replacement (total or partial)
    -Signature of informed consent from the patient or their legal representative
    -Pacientes mayores de 18 años
    -Pacientes con fractura unilateral subcapital de fémur
    -Pacientes que requieran una prótesis de cadera (total o parcial)
    -Firma del consentimiento informado del paciente o de su representante legal
    E.4Principal exclusion criteria
    -Multiple fractures
    -That the patient did not give informed consent or their legal
    -Known allergy-fibrin glue or tranexamic acid
    -Background compatible with thromboembolic disease:
    ? cerebrovascular accident
    ? Coronary heart disease (myocardial infarction, angina)
    ? Deep vein thrombosis
    ? Pulmonary embolism
    ? peripheral arterial vascular disease
    ? Patients with thrombogenic arrhythmias
    ? Patients with prosthetic heart
    ? Coagulation disorders prothrombotic
    -Contraceptives, or estrogen therapy
    - Use of recuperators blood during surgery
    -Treatment with iron-on post-operative
    Alergia conocida al ATX o a la cola de fibrina
    Antecedentes compatibles con enfermedad tromboembólica:
    -Múltiples fracturas
    -Que el paciente no dé su consentimiento informado o su responsable legal
    -Alergia conocida a la cola de fibrina o al ácido tranexámico
    -Antecedentes compatibles con enfermedad tromboembólica:
    ? Accidente vascular cerebral (AVC, AIT)
    ? Cardiopatía isquémica (IAM, ángor)
    ? Trombosis venosa profunda (TVP) y/o superficial
    ? Tromboembolismo Pulmonar (TEP)
    ? Vasculopatía arterial periférica
    ? Pacientes con arritmias trombogénicas (ejempl: AcxFA)
    ? Pacientes portadores de prótesis cardiovasculares
    ? Alteraciones de la coagulación protrombóticas
    -Tratamiento con anticonceptivos o estrógenos
    - Uso de recuperadores de sangre durante la intervención quirúrgica
    -Tratamiento con hierro en el post-operatorio
    E.5 End points
    E.5.1Primary end point(s)
    ? To assess whether tranexamic acid or fibrin glue administered topically reduce at least 25% blood loss with respect to control in patients undergoing subcapital fracture of the femur.
    ? Evaluar si el ácido tranexámico o la cola de fibrina administrados vía tópica reducen al menos en un 25% la pérdida sanguínea con respecto al control en pacientes intervenidos de fractura subcapital de fémur.
    E.5.1.1Timepoint(s) of evaluation of this end point
    First 24 postoperative hours
    Primeras 24 h postoperatorias
    E.5.2Secondary end point(s)
    1. Hidden blood loss calculated from the formula of Nadler (1962).
    2. Proportion of patients requiring blood transfusion in the postoperative
    3. Preoperative and postoperative hemoglobin
    4. Number. of blood transfusions
    5. Units of blood transfusions administered
    6. Incidence of wound infection
    7. Pain patient's associated with the surgical wound
    8. Days in hospital
    9. Side effects associated with interventions
    10. Hospital mortality
    1. Pérdida de sangre oculta calculada a partir de la fórmula de Nadler (1962).
    2. Proporción de pacientes que necesitan transfusión sanguínea en el postoperatorio
    3. Hemoglobina pre y postoperatoria
    4. Nº de transfusiones sanguíneas
    5. Unidades de transfusiones sanguíneas administradas
    6. Incidencia de infección de la herida
    7. Dolor de la herida quirúrgica del paciente
    8. Días de estancia hospitalaria
    9. Efectos secundarios relacionados con las intervenciones
    10. Mortalidad intrahospitalaria
    E.5.2.1Timepoint(s) of evaluation of this end point
    First 5 postoperative days and 1 month after intervention.
    Primeros 5 días postoperatorios y al mes de la intervención.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Hemostasia con electrocoagulación
    Haemostasia with electrocoagulation
    E.8.2.4Number of treatment arms in the trial4
    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 concerned3
    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
    The last visit of the last subject undergoing the trial
    Última visita del último paciente incluido en el estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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
    Elderly people with impaired consciousness
    Personas ancianas con alteración de la conciencia
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state220
    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)
    The expected normal treatment of that condition
    El tratamiento habitual en este tipo de pacientes
    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 Decision2012-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-15
    P. End of Trial
    P.End of Trial StatusOngoing
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