E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Réanimation post arrêt cardiaque |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10007517 |
E.1.2 | Term | Arrêt cardiaque |
|
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 |
Tester l'efficacité d'un traitement par forte dose d'époétine à la phase initiale de la réanimation de l'arrêt cardio-respiratoire extra-hospitalier (ACEH) en terme de capacité à améliorer le devenir neurologique de ces patients, en addition du traitement habituel.
|
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age compris entre 18 et 80 ans, - ACEH survenu devant témoin, et d'origine cardiaque présumée (non asphyxique), - Délai entre collapsus et début de la réanimation inférieur à 10 minutes ("no flow"), - Délai entre début de la réanimation et reprise d'activité circulatoire (RACS) inférieur à 50 minutes ("low flow"), - Coma persistant après RACS avec Score de Glasgow < 7 à l'inclusion, - Disponibilité d'une place dans un service de réanimation participant à l'étude, - Patient affilié à un régime de sécurité sociale (bénéficiaire ou ayant droit).
|
|
E.4 | Principal exclusion criteria |
- ACEH d'origine non-cardiaque (trauma, sepsis, insuffisance respiratoire aiguë ou autre étiologie asphyxique), - Traitement préalable ou chronique par érythropoïétine ou analogue, - Grossesse, - Maladie sous-jacente rapidement fatale (espérance de vie < 6 mois).
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. critère d'évaluation principal : Le nombre de patients atteignant un niveau 1 sur l'échelle Pittsburgh Cerebral Performance Categories (CPC) dans chaque groupe à J60
2. critères d'évaluation secondaires : - échelle échelle Pittsburgh Cerebral Performance Categories (CPC) à J28 et J60, - mortalité à J28 et J60, effets secondaires et évènements inattendus (incluant les événements thromboemboliques) |
|
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 | No |
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 | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
|
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 | 17 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
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 | 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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |