Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Max-Planck-Institute of Experimental Medicine
• Collaborators: Johnson & Johnson; Parexel
• Treatments: Epoetin Alfa

Criteria

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