Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke

Max-Planck-Institute of Experimental Medicine522 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

522

Conditions

Infarction, Middle Cerebral Artery Middle Cerebral Artery Stroke Stroke, Acute

Interventions

recombinant human erythropoietin alfaDRUG

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

0.9% NaClDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Neurologische Klinik des Städtischen Klinikums Braunschweig

Braunschweig, Germany

Neurologische Klink, Klinikum Bremen-Mitte

Bremen, Germany

Neurologische Klinik, Allgemeines Krankenhaus Celle

Celle, Germany

Outcomes

Primary Outcomes

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

Time frame: day 90

Secondary Outcomes

Modified Rankin Scale (mRS) responder

Time frame: day 90

Barthel Index (BI)

Time frame: day 30

mRS

Time frame: day30, day 90

NIH Stroke Scale

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

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

Time frame: day 30, day 90

All-cause mortality

Time frame: day 90

Mortality directly related to stroke

Time frame: day 90

Proportion of subjects with BI >= 95

Time frame: day 30, day 90

Proportion of subjects with BI=100

Time frame: day 30, day 90

Proportion of subjects with neurological recovery

Time frame: day 3, 7, 30, 90

Distribution of mRS scores

Time frame: day 30, day 90

Distribution of BI scores

Data from ClinicalTrials.gov

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