High Dose of Erythropoietin Analogue After Cardiac Arrest

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2014-05-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Comatose Survivors of Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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EPO

five injections maximum of 40000 UI EPO

Group Type EXPERIMENTAL

EPOETINE ALPHA

Intervention Type DRUG

5 injections of 40000 UI of EPO

Control

Classical take care

Group Type ACTIVE_COMPARATOR

Control arm

Intervention Type OTHER

Usual take care of cardiac arrest

Interventions

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EPOETINE ALPHA

5 injections of 40000 UI of EPO

Intervention Type DRUG

Control arm

Usual take care of cardiac arrest

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No