High Dose of Erythropoietin Analogue After Cardiac Arrest (NCT00999583) | Clinical Trial Compass
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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used high doses of an erythropoietin analogue in comatose survivors of cardiac arrest — is erythropoietin something that has ever been considered in my or my family member's care, and what does my doctor think about the evidence from this completed Phase 3 study?
2The trial measured how many patients reached a CPC level 1, which means good neurological recovery — based on the results of this study, did the erythropoietin treatment actually show a meaningful difference in brain recovery compared to the control group?
3Since this was a Phase 3 trial that has already completed, does my doctor know whether the results influenced any current standard-of-care protocols for comatose cardiac arrest survivors?
4High-dose erythropoietin can affect red blood cell production and has known cardiovascular risks — what serious side effects were observed in this trial, and how would those risks weigh against potential benefits in this specific situation?
5Are there other completed or ongoing studies on neuroprotective treatments after cardiac arrest that my doctor thinks are more promising or better supported by evidence than this erythropoietin approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of patients reaching a CPC (cerebral performance category) level 1 in each group