Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke

German Multicenter EPO Stroke Trial (Phase II/III)

The purpose of this randomized, double-blind, placebo-controlled multicenter study is to determine in a cohort of 506 patients with acute ischemic stroke in the middle cerebral artery territory, the effect of a three-day high-dose, intravenous erythropoietin treatment on functional outcome up to a follow-up of 90 days.

Inclusion Criteria:

• Ischemic stroke in the middle cerebral artery territory
• Clearly defined time of onset
• Confirmed by MRI (DWI, Flair)
• NIH Stroke Scale ≥ 5
• Age > 18 years
• Treatment within 6h after onset of symptoms
• Informed consent by patient, relatives or independent physician
• Life expectancy > 90 days

Exclusion Criteria:

• Coma or precoma (level of consciousness ≥ 2 in NIH Stroke Scale)
• Previous stroke within the same territory
• Intracranial or subarachnoidal hemorrhage
• Traumatic brain injury or brain operation within the last 4 weeks
• Neoplasia, septic embolism, infectious endocarditis
• MRI contraindications
• Renal failure (i.e. dependent on dialysis)
• Known malignant/life-threatening disease
• Known myeloproliferative disorder, polycythemia
• Known allergy or antibodies against erythropoietin
• Participation in other intervention trials
• Pregnancy