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Effect of Early High-dose Epoetin Alfa During Cardiac Arrest (Pilot Study)

This study has been completed.
Sponsor:
Information provided by:
Janssen Cilag S.A.S.
ClinicalTrials.gov Identifier:
NCT00719498
First received: July 17, 2008
Last updated: May 16, 2011
Last verified: April 2010

July 17, 2008
May 16, 2011
November 2003
Not Provided
Primary: Mortality and neurological outcome recorded at day 28
Same as current
Complete list of historical versions of study NCT00719498 on ClinicalTrials.gov Archive Site
All unexpected events in order to detect potential side effects of High-dose Epo administration
Same as current
Not Provided
Not Provided
 
Effect of Early High-dose Epoetin Alfa During Cardiac Arrest (Pilot Study)
Early High-dose Erythropoietin Therapy and Hypothermia After Out-of-hospital Cardiac Arrest: A Matched Control Study

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).

Aim: To test the possible neuroprotective effect of early high-dose erythropoietin alpha after out-of-hospital cardiac arrest (OHCA). Safety, pharmacokinetics and an estimation of potential risks benefits of EPO treatment were evaluated. Methodology: An open labelled, pilot, matched control study. Following resuscitation with mild hypothermia with after OHCA, participants received a first dose of EPO-alpha followed by four additional injections within 48 hours (40 000 IU intravenously each injection). Plasma Epo-alpha levels were measured at different time points. Outcome and adverse events were assessed up to day 28 and were compared with those of matched-paired controls Pilot, open-labelled, matched controls study performed between Nov 2003 and May 2004. As the first step, the effect of high-dose Epo-alpha for 20 consecutive patients with OHCA who had been successfully resuscitated by the emergency medical service was studied. The participants received the first dose of Epo-alpha as soon as possible after stable ROSC, followed by an additional injection every 12h during the first 48 hours ICU admission (40 000 IU intravenously each injection). Collected data included demographics, clinical characteristics, biological features, treatment and outcome. Severity was assessed by the Simplified Acute Physiologic Score 2 (SAPS2). Mortality and neurological outcome were recorded at day 28. All unexpected events were assessed in order to detect potential side effects of High-dose Epo administration. As the second step, the outcomes observed among the prospective Epo-treated patients were compared to the cohort with outcomes observed among case-matched historical controls. Two matched controls were selected for each Epo-treated patient. Neurological assessment was performed on admission and each day between days 1 and 7, and at days 14, 21 and 28. Blood samples were drawn daily from day 1 to day 7 and weekly from day 7 to day 28. For the pharmacokinetics blood samples were drawn just before and at 2h, 4h, 6h, 8h, 10h, 12h, 24h, 36h, 48h, 72h, 78h, 84h, and 96 h after the first administration of Epo-alpha.

Intravenous Epo-alpha: First dose as soon as possible after stable return of spontaneous circulation (ROSC), followed by an additional injection every 12 hours during the first 48 hours. (40 000 IU at each injection)

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Resuscitation
  • Cardiopulmonary
  • Cardiac Arrest
Drug: Epo-alpha
Not Provided
Cariou A, Claessens YE, Pène 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. Epub 2007 Nov 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
July 2004
Not Provided

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00719498
CR005008
Not Provided
Not Provided
Janssen Cilag S.A.S.
Not Provided
Study Director: Janssen-Cilag S.A.S. Clinical Trial Janssen Cilag S.A.S.
Janssen Cilag S.A.S.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP