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

M

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

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

Trial contacts and locations

9

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Data sourced from clinicaltrials.gov

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