E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gastrointestinal hemorrhage |
Hemorragia gastrointestinal |
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E.1.1.1 | Medical condition in easily understood language |
Bleeding from the gut |
Sangrado intestinal |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10017960 |
E.1.2 | Term | Gastrointestinal hemorrhage |
E.1.2 | System Organ Class | 100000004856 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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. |
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E.2.2 | Secondary 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). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary 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). |
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E.5.1.1 | Timepoint(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.5.2 | Secondary 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 |
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E.5.2.1 | Timepoint(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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 40 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 300 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If 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 |
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E.8.7 | Trial 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. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |