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

Completed

Phase 2/3 Results

Trial Description

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.

Conditions

Interventions

  • Epoetin Alfa (Procrit and Epogen)Drug
    Other Names: Procrit
    Intervention Desc: Used to treat anemia, to decrease the need for red blood cell transfusions. Usually given by subcutaneous injection.
  • Saline Drug
    Other Names: Sodium Chloride
    Intervention Desc: Used as placebo for injection.
  • Recombinant human erythropoietin alfa Drug
    Other Names: ERYPO
    Intervention Desc: 40,000 IU in 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
    ARM 1: Kind: Experimental
    Label: verum
    Description: erythropoietin alfa 40,000 IU iv in 50ml 0.9% NaCl
  • 0.9% NaCl Drug
    Intervention Desc: 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
    ARM 1: Kind: Experimental
    Label: placebo
    Description: 50ml 0.9% NaCL

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to one of two arms and receive either saline placebo of 50ml iv on 3 consecutive days starting within 6 hours after onset of symptoms or erythropoietin alfa 40,000 IU on 3 consecutive days starting within 6 hours after onset of symptoms. In addition patient will be assessed for various neurological exams on day 1, 2, 3, 4, 7, 30 & 90 daysafter treatment.

Outcomes

Type Measure Time Frame Safety Issue
Primary Neurological/functional outcome as measured by the Barthel Index (BI).
Secondary Modified Rankin Scale (mRS) responder; Barthel Index (BI); mRS; NIH Stroke Scale; proportion of subjects with minimal disability (mRS 0-1); all-cause mortality; Mortality directly related to stroke; proportion of subjects with BI>=95; proportion of subjects with BI=100; proportion of subjects with neurological recovery; distribution of mRS scores; distribution of BI scores; distribution of NIH Stroke Scale scores; serum level of glial damage markers S100B and GFAP; lesion size (MRI DWI, flair); overall survival; late recovery index (BI day 90 versus BI day 30).
Primary Neurological/functional outcome as measured by the Barthel Index (BI) day 90 No
Secondary Modified Rankin Scale (mRS) responder day 90 No
Secondary Barthel Index (BI) day 30 No
Secondary mRS day30, day 90 No
Secondary NIH Stroke Scale day 1, 3, 7, 30, 90 No
Secondary Proportion of subjects with minimal disability (mRS 0-1) day 30, day 90 No
Secondary All-cause mortality day 90 Yes
Secondary Mortality directly related to stroke day 90 Yes
Secondary Proportion of subjects with BI >= 95 day 30, day 90 No
Secondary Proportion of subjects with BI=100 day 30, day 90 No
Secondary Proportion of subjects with neurological recovery day 3, 7, 30, 90 No
Secondary Distribution of mRS scores day 30, day 90 No
Secondary Distribution of BI scores day 30, day 90 No
Secondary Distribution of NIH Stroke Scale scores day 30, day 90 No
Secondary Serum level of glial damage markers S100B and GFAP day 1, 2, 3, 4, 7 No
Secondary Lesion size (MRI DWI, flair) day 1, day 7 No
Secondary Overall survival day 90 Yes
Secondary Late recovery index (BI day 90 versus BI day 30) day 30 to day 90 No

Sponsors