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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2012-003192-19
    Sponsor's Protocol Code Number:ISRCTN11225767
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-03-18
    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 number2012-003192-19
    A.3Full title of the trial
    Tranexamic acid for the treatment of gastrointestinal haemorrhage: an international randomised, double blind placebo controlled trial
    Ácido tranexámico para el tratamiento de la hemorragia gastrointestinal: un ensayo internacional, aleatorio, doble ciego, controlado por 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 gastrointestinal bleeding (bleeding from the gut) - HALT-IT
    Ácido tranexámico para el tratamiento de la hemorragia gastrointestinal (sangrado intestinal) - HALT-IT
    A.3.2Name or abbreviated title of the trial where available
    Haemorrhage alleviation with tranexamic acid- intestinal system[HALT-IT] [Version 1.0]
    Alivio de la hemorragia con ácido tranexámico ? sistema intestinal [HALT-IT] [Version 1.0]
    A.4.1Sponsor's protocol code numberISRCTN11225767
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN11225767
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01658124
    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 supportNIHR-HTA
    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 (Pfizer)
    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/infusion
    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 codeISRCTN11225767
    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 infusion
    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
    Gastrointestinal hemorrhage
    Hemorragia gastrointestinal
    E.1.1.1Medical condition in easily understood language
    Bleeding from the gut
    Sangrado intestinal
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10017960
    E.1.2Term Gastrointestinal hemorrhage
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The HALT-IT trial will find out whether early administration of tranexamic acid improves outcomes for people who suffered of significant gastrointestinal bleeding. The main outcome is death in hospital within 28 days of randomisation. We will also assess the cause of death.
    El ensayo HALT-IT determinará el efecto de una administración temprana de TXA sobre los resultados en pacientes que padecieron sangrado gastrointestinal significativo. El resultado principal es la muerte en el hospital dentro de 28 días de la aleatorización. La causa de muerte también se registrará.
    E.2.2Secondary objectives of the trial
    The secondary objectives will be to assess whether tranexamic acid leads to better outcomes such as reducing re-bleeding, need for surgery or radiological intervention, blood transfusion, number of days spent in intensive care. We will also assess whether there is any increase in serious outcomes including heart attack, stroke and blood clots in the legs or lungs, and seizures. In addition, we will evaluate if there is an improvement in patient's ability to perform the activities of daily living at discharge (bathing, dressing, toileting, transferring, continence and feeding).
    Los resultados secundarios determinarán si el ácido Tranexámico lleva a mejores resultados como la reducción del resangrado la necesidad de intervención quirúrgica, trasfusión de sangre, número de días en cuidados intensivos. Se registrara si hay un incremento en desenlaces serios incluyendo infarto de miocardio, embolia y trombosis en las piernas o pulmones, y convulsiones. Además se evaluara si hay mejora en la habilidad del paciente para ejecutar actividades diarias en el momento de alta del hospital (baño, vestido, aseo personal, transferencia, continencia, alimentación).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Adult (18 years and over) with significant gastrointestinal bleeding
    ? Where the responsible clinician is substantially uncertain as to whether or not to use tranexamic acid
    ? Adultos (mayores de 18 años) con hemorragia gastrointestinal significativa
    ? Existe incertidumbre del médico responsable acerca de si usar o no usar ácido tranexámico en un paciente en particular.
    E.4Principal exclusion criteria
    ? Patients for whom the responsible clinician considers there is a clear indication for tranexamic acid.
    ? Patients for whom the responsible clinician considers there is a clear contraindication for tranexamic acid.
    ? Pacientes para quien el médico responsable considera que hay una indicación clara para el tratamiento con ácido Tranexámico.
    ? Pacientes para quien el médico responsable considera que hay una contraindicación clara para el tratamiento con ácido Tranexámico.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is death in hospital within 28 days after randomisation (cause-specific mortality will also be recorded).
    Se considera como resultado principal la muerte en el hospital durante los primeros 28 días desde la aleatorización (también se registrará la mortalidad por causas específicas).
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days after randomisation, at hospital discharge, or at death whichever occurs first.
    28 dias despues de la aleatorizacion, alta del hospital o muerte, lo que ocurra antes.
    E.5.2Secondary end point(s)
    a) Re-bleeding
    b) Need for surgery or radiological intervention
    c) Blood product transfusion
    d) Thromboembolic events (deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction)
    e) Other complications (including other significant cardiac event, sepsis, pneumonia, respiratory failure, renal failure, liver failure, seizures)
    f) Functional status will be measured by the Katz Index of Independence in Activities of Daily Living at discharge from the randomising hospital or in-hospital at 28 days after randomisation. The Index assesses adequacy of performance in six functions of bathing, dressing, toileting, transferring, continence and feeding. Patients are scored ?yes? or ?no? for independence in each of the functions (score of 6=full function, 4=moderate impairment, and ?2=severe functional impairment)
    g) Days spent in intensive care unit or high dependency unit
    a)Resangrado
    b)Necesidad de cirugía o intervención radiológica
    c)Transfusión de hemoderivados
    d)Episodios tromboembólicos (trombosis venosa profunda, embolia pulmonar, derrame cerebral, infarto de miocardio)
    e)Otras complicaciones (incluyendo otros episodios cardíacos significativos, sepsis, neumonía, fallo respiratorio, fallo renal, fallo hepático, convulsiones)
    f)El estado de funcionalidad se mediará según el índice Katz de independencia en actividades de la vida diaria38 en el momento del alta del hospital de aleatorización o en el hospital a los 28 días de la misma. El índice valora si el desempeño es bueno a partir de seis funciones: bañarse, vestirse, asearse, trasladarse, continencia y alimentarse. Se puntúa la independencia de los pacientes con un ?sí? o un ?no? en cada función (puntuación de 6 = total; 4 = impedimento moderado, y <2 = impedimento grave de la funcionalidad)
    g)Días pasados en la unidad de cuidados intensivos o en la unidad de alta dependencia
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days after randomisation, at discharge from the randomising hospital, or at death (whichever occurs first).
    28 dias despues de la aleatorizacion, alta del hospital o muerte, 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 concerned40
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA300
    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
    Belgium
    Croatia
    Czech Republic
    Egypt
    France
    Georgia
    Greece
    Ireland
    Italy
    Lithuania
    Mexico
    Nigeria
    Pakistan
    Portugal
    Romania
    Slovakia
    Slovenia
    Spain
    Uganda
    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 8,000 patients have been recruited (anticipated to be completed by 31/07/2017), the trial will end when follow-up of the last patient recruited is completed. Follow up is up to 28 days after randomisation.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 8,000 pacientes (proyectada para el 31 de Julio de 2017), el proceso terminará cuando el seguimiento del último paciente se haya completado (máximo 28 dias después de la aleatorización). El Comité de dirección del ensayo (TSC por sus siglas en inglés) puede finalizar antes el ensayo. El Comité de monitorización de datos (DMC) puede aconsejar/recomendar una finalización temprana del ensayo en sus revisiones de los datos desenmascarados.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 200
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 200
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 3800
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4000
    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 2016-03-18. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    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
    Eligible patients have a significant gastrointestinal bleeding, which is a critical emergency. Patient's physical, mental and emotional state may be affected by their blood loss.
    Los pacientes elegibles tienen un sangrado gastrointestinal significativo, lo que es una emergencia crítica. Su estado físico, mental y emocional puede verse afectado por la pérdida de sangre.
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Very elderly and critically ill
    Ancianos y criticamente enfermos
    F.4 Planned number of subjects to be included
    F.4.1In the member state1000
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 5000
    F.4.2.2In the whole clinical trial 8000
    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 over 10 minute to the patient, a maintenance dose is given over 24 hours.
    All patients will receive standard care as per the hospital's clinical guidelines for treatment of GI bleeding both during and after their participation in the trial.
    Una dosis de carga se adminitrara durante 10 minutos al paciente seguida por una dosis de mantenimiento durante 24 horas.
    Todos los pacientes recibirán atención estándar de acuerdo con los protocolos clínicos de manejo habitual del paciente con sangrado gastrointestinal, durante y después de su participación en el estudio.
    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 Decision2016-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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