NCT00719498

Brief Summary

The purpose of this study is to test the possible neuroprotective effect of early high dose erythropoietin alpha after out of hospital cardiac arrest (OHCA).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2003

Shorter than P25 for phase_3

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

November 1, 2003

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2008

Completed
Last Updated

May 17, 2011

Status Verified

April 1, 2010

First QC Date

July 17, 2008

Last Update Submit

May 16, 2011

Conditions

ResuscitationCardiopulmonaryCardiac Arrest

Keywords

Epo-alphaCardiac arrestMild hypothermia

Outcome Measures

Primary Outcomes (1)

  • Primary: Mortality and neurological outcome recorded at day 28

Secondary Outcomes (1)

  • All unexpected events in order to detect potential side effects of High-dose Epo administration

Interventions

Epo-alphaDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have OHCA of presumed cardiac origin
  • Patient's who have delay between the collapse and onset of cardiopulmonary resuscitation (CPR, no flow) less that 10 minutes
  • Patient's who have delay between onset of CPR and return of spontaneous circulation (ROSC, low flow) less than 50 minutes
  • Patient's who have persistent coma with Glasgow Coma Scale (CGS) less that 7 after ROSC

You may not qualify if:

  • Patient's who have cardiac arrest of non-cardiac aetiology
  • Patient who have previous EPO treatment
  • Patient's who are in pregnancy stage
  • Patient's who have evidence of rapidly fatal underlying condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Cariou A, Claessens YE, Pene F, Marx JS, Spaulding C, Hababou C, Casadevall N, Mira JP, Carli P, Hermine O. Early high-dose erythropoietin therapy and hypothermia after out-of-hospital cardiac arrest: a matched control study. Resuscitation. 2008 Mar;76(3):397-404. doi: 10.1016/j.resuscitation.2007.10.003. Epub 2007 Nov 26.

    PMID: 18037223RESULT

Related Links

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Janssen-Cilag S.A.S. Clinical Trial

    Janssen Cilag S.A.S.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 17, 2008

First Posted

July 21, 2008

Study Start

November 1, 2003

Study Completion

July 1, 2004

Last Updated

May 17, 2011

Record last verified: 2010-04