Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke (ESS)

Max-Planck-Institute of Experimental Medicine

Status and phase: Completed; Phase 3; Phase 2

Conditions: Infarction, Middle Cerebral Artery; Stroke, Acute; Middle Cerebral Artery Stroke

Treatments: Drug: recombinant human erythropoietin alfa; Drug: 0.9% NaCl

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00604630

"EPO Stroke Study"

BfArM-4019639/2002

"Ehrenreich EPO Stroke Study"

"Ehrenreich Study"

Details and patient eligibility

About

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.

Enrollment: 522 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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522 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

50ml 0.9% NaCL

Treatment:

Drug: 0.9% NaCl

verum

Active Comparator group

Description:

erythropoietin alfa 40,000 IU iv in 50ml 0.9% NaCl

Treatment:

Drug: recombinant human erythropoietin alfa