High Dose of Erythropoietin Analogue After Cardiac Arrest (Epo-ACR-02)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Comatose Survivors of Cardiac Arrest |
Drug: EPOETINE ALPHA Other: Control arm |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | High Dose of Erythropoietin Analogue After Cardiac Arrest: a Multicentre, Randomised, Controlled Trial (Epo-ACR-02 Trial) |
- Number of patients reaching a CPC (cerebral performance category) level 1 in each group [ Time Frame: at day 60 ] [ Designated as safety issue: Yes ]
- Distribution of patients in CPC (cerebral performance category) scale [ Time Frame: at day 30 and day 60 ] [ Designated as safety issue: Yes ]
- ICU, hospital D30 and D60 mortality [ Time Frame: during hospitalization and at day 30 and day 60 ] [ Designated as safety issue: Yes ]
- All adverse events (including thrombotic events) [ Time Frame: until day 60 ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: EPO
five injections maximum of 40000 UI EPO
|
Drug: EPOETINE ALPHA
5 injections of 40000 UI of EPO
Other Name: EPOETINE ALPHA
|
|
Active Comparator: Control
Classical take care
|
Other: Control arm
Usual take care of cardiac arrest
Other Name: Control arm
|
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 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.
Hypotheses:
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.
Design:
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).
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Alain Cariou, MD, PhD | +33(0)1 58 41 25 01 | alain.cariou@cch.aphp.fr |
| Contact: Raphaël Serreau, MD, PhD | +33(0)1 58 41 11 80 | raphael.serreau@cch.aphp.fr |
| France | |
| Medical intensive care unit of Cochin-St Vincent de Paul university Hospital | Recruiting |
| Paris, France, 75679 | |
| Principal Investigator: Alain Cariou, MD, PhD | |
| Principal Investigator: | Alain Cariou, MD, PhD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00999583 History of Changes |
| Other Study ID Numbers: | P071217 |
| Study First Received: | October 21, 2009 |
| Last Updated: | December 10, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Cardiac arrest erythropoietin post-anoxic encephalopathy neuroprotective drugs |
Additional relevant MeSH terms:
|
Coma Heart Arrest Unconsciousness Consciousness Disorders Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Heart Diseases Cardiovascular Diseases |
Epoetin Alfa Neuroprotective Agents Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions Protective Agents Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013