Comatose Survivors of Cardiac ArrestPhase 3Epo-ACR-02NCT00999583
High Dose of Erythropoietin Analogue After Cardiac Arrest
A Phase 3 study testing EPOETINE ALPHA in people with Comatose Survivors of Cardiac Arrest, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Comatose Survivors of Cardiac Arrest
- What is being tested?
- EPOETINE ALPHA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to May 2014
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Medical intensive care unit of Cochin-St Vincent de Paul university Hospital
Paris, 75679
About this study
Official title: High Dose of Erythropoietin Analogue After Cardiac Arrest: a Multicentre, Randomised, Controlled Trial (Epo-ACR-02 Trial)
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.
Read the 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).
- Conditions
- Comatose Survivors of Cardiac Arrest
- Being tested
- EPOETINE ALPHA, Control arm
- Keywords
- Cardiac arrest, erythropoietin, post-anoxic encephalopathy, neuroprotective drugs
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPOETINE ALPHADrug
5 injections of 40000 UI of EPO
Control armOther
Usual take care of cardiac arrest
| Study group | Role | What they receive |
|---|---|---|
| EPO | Experimental | five injections maximum of 40000 UI EPO Receives: Drug: EPOETINE ALPHA |
| Control | Active comparator | Classical take care Receives: Other: Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients reaching a CPC (cerebral performance category) level 1 in each group
Measured: at day 60
Secondary outcomes (3)
Distribution of patients in CPC (cerebral performance category) scale
Measured: at day 30 and day 60
ICU, hospital D30 and D60 mortality
Measured: during hospitalization and at day 30 and day 60
All adverse events (including thrombotic events)
Measured: until day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Comatose Survivors of Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Alain Cariou, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999583
- Sponsor's protocol ID
- P071217
- Acronym
- Epo-ACR-02
- Status last verified
- Sep 2025
- First submitted
- 21 Oct 2009
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27364049Nishiwaki 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.
PubMed 39301879Madelaine 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.
PubMed 34116828Boissady 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.
PubMed 33198571