High Dose of Erythropoietin Analogue After Cardiac Arrest (Epo-ACR-02)

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Comatose Survivors of Cardiac Arrest

Treatments

Other: Control arm

Drug: EPOETINE ALPHA

Study type

Interventional

Funder types

Other

Identifiers

NCT00999583

P071217

Details and patient eligibility

About

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.

Full description

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).

Enrollment

500 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age between 18 and 80
Witnessed out-of-hospital cardiac arrest, presumed of cardiac origin (non asphyxic)
Time from cardiac arrest and recovery of circulatory activity less than 60 minutes
Persistent coma after ROSC (Coma Glasgow Scale < 7)

Exclusion criteria

Out-of-hospital cardiac arrest with evidence of extra-cardiac cause (trauma, sepsis, acute respiratory insufficiency, asphyxia)
Previous or chronic treatment with erythropoietin or analogues
Pregnancy
Rapidly fatal underlying disease (expected life duration < 6 months)
No social security