Status:
COMPLETED
Effect of Early High-dose Epoetin Alfa During Cardiac Arrest (Pilot Study)
Lead Sponsor:
Janssen Cilag S.A.S.
Conditions:
Resuscitation
Cardiopulmonary
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test the possible neuroprotective effect of early high dose erythropoietin alpha after out of hospital cardiac arrest (OHCA).
Detailed Description
Aim: To test the possible neuroprotective effect of early high-dose erythropoietin alpha after out-of-hospital cardiac arrest (OHCA). Safety, pharmacokinetics and an estimation of potential risks bene...
Eligibility Criteria
Inclusion
- Patients who have OHCA of presumed cardiac origin
- Patient's who have delay between the collapse and onset of cardiopulmonary resuscitation (CPR, no flow) less that 10 minutes
- Patient's who have delay between onset of CPR and return of spontaneous circulation (ROSC, low flow) less than 50 minutes
- Patient's who have persistent coma with Glasgow Coma Scale (CGS) less that 7 after ROSC
Exclusion
- Patient's who have cardiac arrest of non-cardiac aetiology
- Patient who have previous EPO treatment
- Patient's who are in pregnancy stage
- Patient's who have evidence of rapidly fatal underlying condition
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00719498
Start Date
November 1 2003
End Date
July 1 2004
Last Update
May 17 2011
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