NCT00999583

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2009

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 20, 2025

Status Verified

September 1, 2025

Enrollment Period

3.8 years

First QC Date

October 21, 2009

Last Update Submit

November 17, 2025

Conditions

Comatose Survivors of Cardiac Arrest

Keywords

Cardiac arresterythropoietinpost-anoxic encephalopathyneuroprotective drugs

Outcome Measures

Primary Outcomes (1)

  • Number of patients reaching a CPC (cerebral performance category) level 1 in each group

    at day 60

Secondary Outcomes (3)

  • Distribution of patients in CPC (cerebral performance category) scale

    at day 30 and day 60

  • ICU, hospital D30 and D60 mortality

    during hospitalization and at day 30 and day 60

  • All adverse events (including thrombotic events)

    until day 60

Study Arms (2)

EPO

EXPERIMENTAL

five injections maximum of 40000 UI EPO

Drug: EPOETINE ALPHA

Control

ACTIVE COMPARATOR

Classical take care

Other: Control arm

Interventions

EPOETINE ALPHADRUG

5 injections of 40000 UI of EPO

EPO
Control armOTHER

Usual take care of cardiac arrest

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical intensive care unit of Cochin-St Vincent de Paul university Hospital

Paris, 75679, France

Location

Related Publications (4)

  • Cariou A, Deye N, Vivien B, Richard O, Pichon N, Bourg A, Huet L, Buleon C, Frey J, Asfar P, Legriel S, Narcisse S, Mathonnet A, Cravoisy A, Dequin PF, Wiel E, Razazi K, Daubin C, Kimmoun A, Lamhaut L, Marx JS, de la Garanderie DP, Ecollan P, Combes A, Spaulding C, Barat F, Ben Boutieb M, Coste J, Chiche JD, Pene F, Mira JP, Treluyer JM, Hermine O, Carli P; Epo-ACR-02 Study Group. Early High-Dose Erythropoietin Therapy After Out-of-Hospital Cardiac Arrest: A Multicenter, Randomized Controlled Trial. J Am Coll Cardiol. 2016 Jul 5;68(1):40-9. doi: 10.1016/j.jacc.2016.04.040.

    PMID: 27364049RESULT

  • Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.

    PMID: 39301879DERIVED

  • Madelaine T, Cour M, Roy P, Vivien B, Charpentier J, Dumas F, Deye N, Bonnefoy E, Gueugniaud PY, Coste J, Cariou A, Argaud L. Prediction of Brain Death After Out-of-Hospital Cardiac Arrest: Development and Validation of the Brain Death After Cardiac Arrest Score. Chest. 2021 Jul;160(1):139-147. doi: 10.1016/j.chest.2021.01.056. Epub 2021 Jun 8.

    PMID: 34116828DERIVED

  • Boissady E, Kohlhauer M, Lidouren F, Hocini H, Lefebvre C, Chateau-Jouber S, Mongardon N, Deye N, Cariou A, Micheau P, Ghaleh B, Tissier R. Ultrafast Hypothermia Selectively Mitigates the Early Humoral Response After Cardiac Arrest. J Am Heart Assoc. 2020 Dec;9(23):e017413. doi: 10.1161/JAHA.120.017413. Epub 2020 Nov 17.

    PMID: 33198571DERIVED

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Alain Cariou, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 22, 2009

Study Start

October 1, 2009

Primary Completion

July 1, 2013

Study Completion

May 1, 2014

Last Updated

November 20, 2025

Record last verified: 2025-09

Locations

FR(1)