High Dose of Erythropoietin Analogue After Cardiac Arrest

Phase 3

Completed

• Conditions: Comatose Survivors of Cardiac Arrest
• Interventions: Other: Control arm; Drug: EPOETINE ALPHA

• Registration Number: NCT00999583
• Lead Sponsor: 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.

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).

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-21
• Study First Posted: 2009-10-22
• Primary Completion: 2013-07
• Study Completion: 2014-05
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control arm	Classical take care
EPO	EPOETINE ALPHA	five injections maximum of 40000 UI EPO

Primary Outcome Measures

Name	Time	Method
Number of patients reaching a CPC (cerebral performance category) level 1 in each group	at day 60

Secondary Outcome Measures

Name	Time	Method
Distribution of patients in CPC (cerebral performance category) scale	at day 30 and day 60
All adverse events (including thrombotic events)	until day 60
ICU, hospital D30 and D60 mortality	during hospitalization and at day 30 and day 60

Trial Locations

Locations (1)

Medical intensive care unit of Cochin-St Vincent de Paul university Hospital; 🇫🇷 Paris, France