E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary Intracerebral Haemorrhage |
Hemorragia Intracerebral primaria aguda |
|
E.1.1.1 | Medical condition in easily understood language |
Haemorrhagic stroke |
Derrame cerebral |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022753 |
E.1.2 | Term | Intracerebral haemorrhage |
E.1.2 | System Organ Class | 100000004852 |
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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 |
To assess whether tranexamic acid is safe and reduces death or dependency after primary intracerebral haemorrhage (PICH). |
Evaluar si el ácido tranexámico es seguro y reduce la mortalidad y la dependencia tras la hemorragia intracerebralaguda primaria (HICP). |
|
E.2.2 | Secondary objectives of the trial |
To assess the effect of tranexamic acid on secondary outcomes: clinical outcomes, safety outcomes, costs and radiological efficacy. |
Evaluar el efecto del ácidotranexámico en términos de pronóstico clínico, seguridad, costes económicos y eficacia radiológica. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adult (?18 years) patients with acute PICH within 8 hours of stroke onset. (Where stroke onset time is unknown, the time of when last known well will be used.) |
Adultos (?18 years) se incluirán aquellos pacientes que se encuentren en sus primeras 8 horas tras sufrir accidente hemorrágico intracerebral agudo espontáneo. (Cuando el inicio del accidente hemorrágico intracerebral sea desconocido, será utilizado como inicio el momento desde su conocimiento) |
|
E.4 | Principal exclusion criteria |
1) Patients with intracerebral haemorrhage secondary to anticoagulation, thrombolysis or known underlying structural abnormality such as arterial venous malformation, aneurysm, tumour, venous thrombosis as cause for the intracerebral haemorrhage.. Note it is not necessary to exclude an underlying abnormality prior to enrolment, but where a secondary cause of haemorrhage is known, these patients should not be recruited. 2) Patients for whom tranexamic acid is thought to be contraindicated. 3) Patients with pre-morbid dependency (mRS>4). 4) Participation in another drug trial concurrently. 5) Pre-stroke life expectancy <3 months (eg. advanced metastatic cancer). 6) Coma ? Glasgow coma scale <5 |
1) Pacientes con hemorragia intracerebral secundaria a tratamiento anticoagulante, trombolísis o anomalía estructural subyacente conocida, como malformación arteriovenosa, aneurisma, tumor, trombosis venosa. Señalar que hasta conocerse la existencia de una lesión subyacente, los pacientes serán susceptibles de ser reclutados en el estudio. Una vez se conozca la existencia de una causa subyacente responsable del sangrado cerebral el paciente será retirado del estudio. 2) Contraindicación para recibir ácido tranexámico. 3) Factores geográficos o de otro tipo, que impidan el seguimiento de los pacientes a los 90 días de evolución. 4) Participación en otro ensayo clínico, salvo si se trata del estudio de prevención secundaria RESTART. Los participantes inscritos en el TICH-2 pueden reclutarse en el ensayo RESTART transcurridos 21 días. 5-6)Discapacidad previa grave (escala de Rankin modificada> 4), escala de coma de Glasgow <5, o esperanza de vida <3 meses debido a otra enfermedad concomitante (por ejemplo cáncer metastásico avanzado). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To assess whether tranexamic acid is safe and reduces death or dependency after primary intracerebral haemorrhage (PICH). |
Evaluar si el ácido tranexámico es seguro y reduce la mortalidad y la dependencia tras la hemorragia intracerebralaguda primaria (HICP). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Death or dependency (ordinal shift on mRS) at day 90 will be compared between tranexamic acid and saline. |
Muerte o dependencia en el día 90 de evolución (según la escala de Rankin modificada) comparada entre el ácido tranexámico y placebo. |
|
E.5.2 | Secondary end point(s) |
1. Neurological impairment (NIHSS) at day 7 or discharge if sooner. 2. Disability (Barthel index) at day 90, 3. Quality of Life (EuroQol) at day 90, 4. Cognition at day 90. 5. Costs: length of stay in hospital, re-admission, institutionalisation. 6. Radiological efficacy/safety (CT scan): change in haematoma volume from baseline to day 2, haematoma location and new infarction. |
1) Deterioro neurológico (NIHSS) en el día 7º (o al alta si ésta es anterior). 2) Discapacidad (índice de Barthel, mRS) en el día 90º. 3) Calidad de vida (EuroQol) en el día 90º. 4) Estado cognitivo y estado de ánimo (TICS y ZDS) en el día 90º. 5) Coste: duración de la estancia hospitalaria, reingreso, institucionalización. 6) Eficacia / seguridad radiológica (TAC): cambios en el volumen del hematoma transcurridas 24 horas, ubicación del hematoma, infarto de nueva aparición. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
See above for details: Day 2, Day 7 and 90 days |
Observaciones: Día 2, Día 7 y 90 días. |
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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 | No |
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 | 80 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 15 |
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 |
Australia |
Canada |
Denmark |
Egypt |
Hong Kong |
India |
New Zealand |
Poland |
Romania |
Sri Lanka |
Sweden |
|
E.8.7 | Trial 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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |