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
  Purpose

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).


Condition Intervention Phase
Resuscitation
Cardiopulmonary
Cardiac Arrest
Drug: Epo-alpha
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early High-dose Erythropoietin Therapy and Hypothermia After Out-of-hospital Cardiac Arrest: A Matched Control Study

Resource links provided by NLM:


Further study details as provided by Janssen Cilag S.A.S.:

Primary Outcome Measures:
  • Primary: Mortality and neurological outcome recorded at day 28

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

Enrollment: 20
Study Start Date: November 2003
Study Completion Date: July 2004
Detailed Description:

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)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00719498

Sponsors and Collaborators
Janssen Cilag S.A.S.
Investigators
Study Director: Janssen-Cilag S.A.S. Clinical Trial Janssen Cilag S.A.S.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00719498     History of Changes
Other Study ID Numbers: CR005008
Study First Received: July 17, 2008
Last Updated: May 16, 2011
Health Authority: France: Ministry of Health

Keywords provided by Janssen Cilag S.A.S.:
Epo-alpha
Cardiac arrest
Mild hypothermia

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 01, 2014