Cardiac Arrest Clinical Trial
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).
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)
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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