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Completed

NCT Number: NCT00604630

Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke

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.

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Key information

Conditions

Infarction, Middle Cerebral Artery Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebral Infarction Cerebrovascular Disorders Hypoxia Infarction Intracranial Arterial Diseases Ischemia Middle Cerebral Artery Stroke Necrosis Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Stroke Stroke, Acute Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Neurologische Klinik des Städtischen Klinikums Braunschweig, Braunschweig, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

recombinant human erythropoietin alfa

Drug

40,000 IU in 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms

Other names: ERYPO

0.9% NaCl

Drug

50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms

Primary outcomes

  1. Neurological/functional outcome as measured by the Barthel Index (BI)

    Time frame: day 90

Secondary outcomes

  1. Modified Rankin Scale (mRS) responder

    Time frame: day 90

  2. Barthel Index (BI)

    Time frame: day 30

  3. mRS

    Time frame: day30, day 90

  4. NIH Stroke Scale

    Time frame: day 1, 3, 7, 30, 90

  5. Proportion of subjects with minimal disability (mRS 0-1)

    Time frame: day 30, day 90

  6. All-cause mortality

    Time frame: day 90

  7. Mortality directly related to stroke

    Time frame: day 90

  8. Proportion of subjects with BI >= 95

    Time frame: day 30, day 90

  9. Proportion of subjects with BI=100

    Time frame: day 30, day 90

  10. Proportion of subjects with neurological recovery

    Time frame: day 3, 7, 30, 90

  11. Distribution of mRS scores

    Time frame: day 30, day 90

  12. Distribution of BI scores

    Time frame: day 30, day 90

  13. Distribution of NIH Stroke Scale scores

    Time frame: day 30, day 90

  14. Serum level of glial damage markers S100B and GFAP

    Time frame: day 1, 2, 3, 4, 7

  15. Lesion size (MRI DWI, flair)

    Time frame: day 1, day 7

  16. Overall survival

    Time frame: day 90

  17. Late recovery index (BI day 90 versus BI day 30)

    Time frame: day 30 to day 90

Sponsors and collaborators

Lead sponsor

Max-Planck-Institute of Experimental Medicine

Other

Collaborators

  • Johnson & Johnson
  • Parexel

Registry information

Official study title

German Multicenter EPO Stroke Trial (Phase II/III)

Acronym: ESS

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jan 30, 2008
Registry last updated
Oct 22, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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