Infarction, Middle Cerebral Artery, Middle Cerebral Artery Stroke, Stroke, Acute
Conditions
Keywords
stroke, EPO, erythropoietin, ischemia, hypoxia, antiapoptosis, neuroprotection, rtPA, thrombolysis, stroke, middle cerebral artery, Ischemic stroke in the middle cerebral artery territory
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.
Interventions
DRUGrecombinant human erythropoietin alfa
40,000 IU in 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
DRUG0.9% NaCl
50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
Sponsors
Johnson & Johnson
Parexel
Max-Planck-Institute of Experimental Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neurological/functional outcome as measured by the Barthel Index (BI) | day 90 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Modified Rankin Scale (mRS) responder | day 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 |
| Proportion of subjects with neurological recovery | day 3, 7, 30, 90 |
Countries
Germany
Outcome results
None listed