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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00999583
Recruitment Status : Completed
First Posted : October 22, 2009
Last Update Posted : June 26, 2014
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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 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.

Condition or disease Intervention/treatment Phase
Comatose Survivors of Cardiac Arrest Drug: EPOETINE ALPHA Other: Control arm Phase 3

Detailed Description:


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.


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.


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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High Dose of Erythropoietin Analogue After Cardiac Arrest: a Multicentre, Randomised, Controlled Trial (Epo-ACR-02 Trial)
Study Start Date : October 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

Arm Intervention/treatment
Experimental: EPO
five injections maximum of 40000 UI EPO
5 injections of 40000 UI of EPO

Active Comparator: Control
Classical take care
Other: Control arm
Usual take care of cardiac arrest

Primary Outcome Measures :
  1. Number of patients reaching a CPC (cerebral performance category) level 1 in each group [ Time Frame: at day 60 ]

Secondary Outcome Measures :
  1. Distribution of patients in CPC (cerebral performance category) scale [ Time Frame: at day 30 and day 60 ]
  2. ICU, hospital D30 and D60 mortality [ Time Frame: during hospitalization and at day 30 and day 60 ]
  3. All adverse events (including thrombotic events) [ Time Frame: until day 60 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00999583

Medical intensive care unit of Cochin-St Vincent de Paul university Hospital
Paris, France, 75679
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Alain Cariou, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00999583     History of Changes
Other Study ID Numbers: P071217
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: June 26, 2014
Last Verified: June 2014

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cardiac arrest
post-anoxic encephalopathy
neuroprotective drugs

Additional relevant MeSH terms:
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Epoetin Alfa