Comatose Survivors of Cardiac Arrest Clinical Trial
Official title:
High Dose of Erythropoietin Analogue After Cardiac Arrest: a Multicentre, Randomised, Controlled Trial (Epo-ACR-02 Trial)
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).
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment