E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Enfermedad de corazon/cirugia cardiaca. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Classification code | 10061026 |
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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 |
Evaluar la seguridad del factor VII recombinante activado (rFVIIa) en el tratamiento de las hemorragias postoperatorias en pacientes tras cirugia cardiaca con circulacion extracorporea. |
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E.2.2 | Secondary objectives of the trial |
Evaluar la eficacia del factor VII recombinante activado (rFVIIa) en el tratamiento de las hemorragias postoperatorias en pacientes tras cirugia cardiaca con circulacion extracorporea. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Consentimiento informado abtenido antes de cualquier actividad relacionada con el ensayo. - Edad mayor o igual a 18 años. - Paciente programado para una cirugia cardiaca que vaya a necesitar circulacion extracorporea. - Hemorragia postoperatoria en los drenajes mediastinicos definida por al menos una de: mayor o igual a 200 ml/hora en cualquier hora completa o parte de ella, o mayor o igual a 4 ml/kg/hora en cualquier hora completa o parte de ella, o mayor o igual a 2ml/kg/hora durante 2 horas consecutivas (se define "parte de ella" como cualquier periodo de 30 minutos posterior al periodo de estabilizacion). - Que el paciente no precise reoperacion urgente cuando cumpla criterio nº5, a juicio del investigador.
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E.4 | Principal exclusion criteria |
- Embarazo o lactancia (si es pertinente) - Primera cirugia de puente aortocoronario o primera sustitucion de una sola valvula con valores preoperatorios de coagulacion normales y una o ninguna mediacion antiplaquetaria en los 5 dias previos a la curugia. - Transplante cardiaco o cardiopulmonar. - Negarse a recibir sangre o hemoderivados debido a razones religiosas o de otra indole. - Cualquier antecedente de accidente cerebrovascular o trastornos tromboticos no coronarios (entre ells TVP, EP) - Signos clinicos compatibles con enfermedad trombotica no coronaria. - Deficit congenito conodido de Proteina S, Proteina C, antitrombina o homocigosis para el factor V de Leiden. - Paciente con resgo inaciptable de trombosis, a juicio del invastigador. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Acontecimientos Adversos Graves y criticos (desde el comierzo de administracion del producto hasta el dia 30) Fallecimiento. Infarto agudo de miocardio (IAM) Infarto cerebral. Embolia pulmonar (EP) clinicamente sintomatica. Otros acontecimientos tromboticos clinicamente sintomaticos. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
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Ultima visita del ultimo paciente. |
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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 | |
E.8.9.1 | In the Member State concerned months | 17 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 17 |