Status:
COMPLETED
High Dose of Erythropoietin Analogue After Cardiac Arrest
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Comatose Survivors of Cardiac Arrest
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 de...
Detailed 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 cardia...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00999583
Start Date
October 1 2009
End Date
May 1 2014
Last Update
November 20 2025
Active Locations (1)
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1
Medical intensive care unit of Cochin-St Vincent de Paul university Hospital
Paris, France, 75679