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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00999583
First received: October 21, 2009
Last updated: June 25, 2014
Last verified: June 2014
  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)

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Number of patients reaching a CPC (cerebral performance category) level 1 in each group [ Time Frame: at day 60 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 500
Study Start Date: October 2009
Study Completion Date: May 2014
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00999583

Locations
France
Medical intensive care unit of Cochin-St Vincent de Paul university Hospital
Paris, France, 75679
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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: June 25, 2014
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:
Heart Arrest
Cardiovascular Diseases
Heart Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014