High Dose of Erythropoietin Analogue After Cardiac Arrest (Epo-ACR-02)
|Comatose Survivors of Cardiac Arrest||Drug: EPOETINE ALPHA Other: Control arm||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||High Dose of Erythropoietin Analogue After Cardiac Arrest: a Multicentre, Randomised, Controlled Trial (Epo-ACR-02 Trial)|
- Number of patients reaching a CPC (cerebral performance category) level 1 in each group [ Time Frame: at day 60 ]
- Distribution of patients in CPC (cerebral performance category) scale [ Time Frame: at day 30 and day 60 ]
- ICU, hospital D30 and D60 mortality [ Time Frame: during hospitalization and at day 30 and day 60 ]
- All adverse events (including thrombotic events) [ Time Frame: until day 60 ]
|Study Start Date:||October 2009|
|Study Completion Date:||May 2014|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
five injections maximum of 40000 UI EPO
Drug: EPOETINE ALPHA
5 injections of 40000 UI of EPO
Active Comparator: Control
Classical take care
Other: Control arm
Usual take care of cardiac arrest
A recent pilot study showed encouraging results regarding the potentially beneficial effects of high dose epoetin alpha (an analogue of erythropoietin) when administered early after cardiac arrest. In this open label and non randomized trial, a high proportion of patients survived without significant cerebral disability and without experiencing severe adverse events (CARIOU et al. Resuscitation 2008). Efficiency of this treatment should now be evaluated in a randomized trial.
An early administration of a high dose of epoetin alpha (Epo) after cardiac arrest resuscitation could improve the neurological outcome of these patients by comparison with standard treatment. The proportion of patients reaching the level 1 of the Pittsburgh CPC scale (i.e., no or minor cerebral disability) at day 60 could attain 45% in the interventional group versus 30% as expected in the control group.
Multicentre, randomised, controlled, simple blind trial ("add on study").
To test the efficiency of a high dose of Epo administered at the early stage of the post-cardiac arrest period regarding its ability to improve the neurological outcome of these patients, when compared with standard care (including hypothermia when indicated).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999583
|Medical intensive care unit of Cochin-St Vincent de Paul university Hospital|
|Paris, France, 75679|
|Principal Investigator:||Alain Cariou, MD, PhD||Assistance Publique - Hôpitaux de Paris|