ResuscitationPhase 3NCT00719498
Effect of Early High-dose Epoetin Alfa During Cardiac Arrest (Pilot Study)
A Phase 3 study testing Epo-alpha in people with Resuscitation and Cardiopulmonary, run by Janssen Cilag S.A.S..
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Resuscitation, Cardiopulmonary, Cardiac Arrest
- What is being tested?
- Epo-alpha
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Jul 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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).
Read the 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)
- Conditions
- Resuscitation, Cardiopulmonary, Cardiac Arrest
- Being tested
- Epo-alpha
- Keywords
- Epo-alpha, Cardiac arrest, Mild hypothermia
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epo-alphaDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startNov 2003
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ResuscitationStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Cilag S.A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag S.A.S. Clinical Trial, Study director, Janssen Cilag S.A.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719498
- Sponsor's protocol ID
- CR005008
- Status last verified
- Apr 2010
- First submitted
- 17 Jul 2008
- Last updated
- 17 May 2011
- Results posted
- No
Publications
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.
PubMed 18037223
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early High-dose Erythropoietin Therapy and Hypothermia After Out-of-hospital Cardiac Arrest: A Matched Control Study
- ClinicalTrials.gov ID
- NCT00719498
- Acronym / sponsor ID
- CR005008
- Conditions
- Resuscitation, Cardiopulmonary, Cardiac Arrest
- Keywords
- Epo-alpha, Cardiac arrest, Mild hypothermia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Janssen Cilag S.A.S.Industry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Jul 2004 (actual)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epo-alpha | Drug | – |
Primary outcome
Primary: Mortality and neurological outcome recorded at day 28
1 secondary outcome
All unexpected events in order to detect potential side effects of High-dose Epo administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
- Results publication: PubMed 18037223Cariou 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.
- Effect of early high-dose Epoetin alfa during cardiac arrest (pilot study)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag S.A.S. Clinical Trial study director
Janssen Cilag S.A.S.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epo-alpha in people with Resuscitation and Cardiopulmonary, run by Janssen Cilag S.A.S..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary: Mortality and neurological outcome recorded at day 28. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00719498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2011.