High Dose of Erythropoietin Analogue After Cardiac Arrest

Comatose Survivors of Cardiac Arrest Clinical Trial

— Epo-ACR-02  

Official title:

High Dose of Erythropoietin Analogue After Cardiac Arrest: a Multicentre, Randomised, Controlled Trial (Epo-ACR-02 Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999583
• Other study ID #: P071217
• Status: Completed
• Phase: Phase 3
• First received: October 21, 2009
• Last updated: June 25, 2014
• Start date: October 2009
• Est. completion date: May 2014

Study information

• Verified date: June 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: May 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Comatose Survivors of Cardiac Arrest
• Heart Arrest

Intervention

Drug:
• EPOETINE ALPHA
5 injections of 40000 UI of EPO

Other:
• Control arm
Usual take care of cardiac arrest

Locations

Country	Name	City	State
France	Medical intensive care unit of Cochin-St Vincent de Paul university Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients reaching a CPC (cerebral performance category) level 1 in each group		at day 60	Yes
Secondary	Distribution of patients in CPC (cerebral performance category) scale		at day 30 and day 60	Yes
Secondary	ICU, hospital D30 and D60 mortality		during hospitalization and at day 30 and day 60	Yes
Secondary	All adverse events (including thrombotic events)		until day 60	Yes