Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke

Phase 2

Completed

• Conditions: Infarction, Middle Cerebral Artery; Middle Cerebral Artery Stroke; Stroke, Acute
• Interventions: Drug: 0.9% NaCl; Drug: recombinant human erythropoietin alfa

• Registration Number: NCT00604630
• Lead Sponsor: Max-Planck-Institute of Experimental Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2008-01-17
• Study First Submitted QC: 2008-01-29
• Study First Posted: 2008-01-30
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Status Verified: 2008-09
• Last Update Submitted: 2008-10-21
• Last Update Posted: 2008-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 522

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	0.9% NaCl	50ml 0.9% NaCL
verum	recombinant human erythropoietin alfa	erythropoietin alfa 40,000 IU iv in 50ml 0.9% NaCl

Primary Outcome Measures

Name	Time	Method
Neurological/functional outcome as measured by the Barthel Index (BI)	day 90

Secondary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS) responder	day 90
Barthel Index (BI)	day 30
mRS	day30, day 90
NIH Stroke Scale	day 1, 3, 7, 30, 90
Proportion of subjects with minimal disability (mRS 0-1)	day 30, day 90
All-cause mortality	day 90
Mortality directly related to stroke	day 90
Proportion of subjects with BI >= 95	day 30, day 90
Proportion of subjects with BI=100	day 30, day 90
Proportion of subjects with neurological recovery	day 3, 7, 30, 90
Distribution of mRS scores	day 30, day 90
Distribution of BI scores	day 30, day 90
Distribution of NIH Stroke Scale scores	day 30, day 90
Serum level of glial damage markers S100B and GFAP	day 1, 2, 3, 4, 7
Lesion size (MRI DWI, flair)	day 1, day 7
Overall survival	day 90
Late recovery index (BI day 90 versus BI day 30)	day 30 to day 90

Trial Locations

Locations (9)

Neurologische Klink, Klinikum Bremen-Mitte; 🇩🇪 Bremen, Germany

Klinik und Poliklinik für Neurologie, Universitätsklinikum Carl Gustav Carus der TU Dresden; 🇩🇪 Dresden, Germany

Neurologische Klinik des Städtischen Klinikums Braunschweig; 🇩🇪 Braunschweig, Germany

Neurologische Universitätsklinik der Georg-August-Universität Goettingen; 🇩🇪 Goettingen, Germany

Neurologische Klinik, Allgemeines Krankenhaus Celle; 🇩🇪 Celle, Germany

Neurologische Klinik, Universität Erlangen-Nürnberg; 🇩🇪 Erlangen, Germany

Klinik für Neurologie, Universität Essen; 🇩🇪 Essen, Germany

Klinik und Poliklinik für Neurologie der Universität Leipzig; 🇩🇪 Leipzig, Germany

Neurologische Klinik, Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany