A Phase 3 interventional study of EPOETINE ALPHA and Control arm in Comatose Survivors of Cardiac Arrest, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
The investigators hypothesised that the neuroprotective effects of erythropoietin and its analogues could lead to an improve outcome after cardiac arrest. To test this hypotheses, the investigators designed a randomized, multicentre, simple blind trial in which all participating patients will be receive usual treatments and 50% of them will also receive a high dose of epoetin alpha (an analogue of erythropoietin) in an "add on" fashion. The main end point will be the proportion of patients in each arm who will reach at day 60 the best level of recovery, using a 5 level score.
Rationale:
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.
Hypotheses:
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.
Design:
Multicentre, randomised, controlled, simple blind trial ("add on study").
Main goal:
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).
966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.
This study's enrollment of 500 is above the median of 100 across 557 interventional studies indexed under Heart Arrest.
Browse Heart Arrest studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
five injections maximum of 40000 UI EPO
Drug: EPOETINE ALPHA
Classical take care
Other: Control arm
5 injections of 40000 UI of EPO
Usual take care of cardiac arrest
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
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris