CompletedPhase 3

High Dose of Erythropoietin Analogue After Cardiac Arrest

France500 participantsStarted 2009-10

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of patients reaching a CPC (cerebral performance category) level 1 in each group

Timeframe: at day 60

Trial details

NCT IDNCT00999583

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-07

View on ClinicalTrials.gov More Comatose Survivors of Cardiac Arrest trials