Multicenter Efficacy Study of Recombinant Human Erythropoietin in Acute Ischemic Stroke
NCT ID: NCT00604630
Last Updated: 2008-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
522 participants
INTERVENTIONAL
2003-01-31
2008-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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placebo
50ml 0.9% NaCL
0.9% NaCl
50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
verum
erythropoietin alfa 40,000 IU iv in 50ml 0.9% NaCl
recombinant human erythropoietin alfa
40,000 IU in 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
Interventions
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recombinant human erythropoietin alfa
40,000 IU in 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
0.9% NaCl
50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Johnson & Johnson
INDUSTRY
Parexel
INDUSTRY
Max-Planck-Institute of Experimental Medicine
OTHER
Responsible Party
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Max-Planck-Institute of Experimental Medicine
Locations
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Neurologische Klinik des Städtischen Klinikums Braunschweig
Braunschweig, , Germany
Neurologische Klink, Klinikum Bremen-Mitte
Bremen, , Germany
Neurologische Klinik, Allgemeines Krankenhaus Celle
Celle, , Germany
Klinik und Poliklinik für Neurologie, Universitätsklinikum Carl Gustav Carus der TU Dresden
Dresden, , Germany
Neurologische Klinik, Universität Erlangen-Nürnberg
Erlangen, , Germany
Klinik für Neurologie, Universität Essen
Essen, , Germany
Neurologische Universitätsklinik der Georg-August-Universität Goettingen
Göttingen, , Germany
Neurologische Klinik, Medizinische Hochschule Hannover
Hanover, , Germany
Klinik und Poliklinik für Neurologie der Universität Leipzig
Leipzig, , Germany
Countries
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References
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Siren AL, Fratelli M, Brines M, Goemans C, Casagrande S, Lewczuk P, Keenan S, Gleiter C, Pasquali C, Capobianco A, Mennini T, Heumann R, Cerami A, Ehrenreich H, Ghezzi P. Erythropoietin prevents neuronal apoptosis after cerebral ischemia and metabolic stress. Proc Natl Acad Sci U S A. 2001 Mar 27;98(7):4044-9. doi: 10.1073/pnas.051606598. Epub 2001 Mar 20.
Ehrenreich H, Hasselblatt M, Dembowski C, Cepek L, Lewczuk P, Stiefel M, Rustenbeck HH, Breiter N, Jacob S, Knerlich F, Bohn M, Poser W, Ruther E, Kochen M, Gefeller O, Gleiter C, Wessel TC, De Ryck M, Itri L, Prange H, Cerami A, Brines M, Siren AL. Erythropoietin therapy for acute stroke is both safe and beneficial. Mol Med. 2002 Aug;8(8):495-505.
Lewczuk P, Hasselblatt M, Kamrowski-Kruck H, Heyer A, Unzicker C, Siren AL, Ehrenreich H. Survival of hippocampal neurons in culture upon hypoxia: effect of erythropoietin. Neuroreport. 2000 Nov 9;11(16):3485-8. doi: 10.1097/00001756-200011090-00017.
Siren AL, Knerlich F, Poser W, Gleiter CH, Bruck W, Ehrenreich H. Erythropoietin and erythropoietin receptor in human ischemic/hypoxic brain. Acta Neuropathol. 2001 Mar;101(3):271-6. doi: 10.1007/s004010000297.
Herrmann M, Ehrenreich H. Brain derived proteins as markers of acute stroke: their relation to pathophysiology, outcome prediction and neuroprotective drug monitoring. Restor Neurol Neurosci. 2003;21(3-4):177-90.
Ehrenreich H, Hasselblatt M, Knerlich F, von Ahsen N, Jacob S, Sperling S, Woldt H, Vehmeyer K, Nave KA, Siren AL. A hematopoietic growth factor, thrombopoietin, has a proapoptotic role in the brain. Proc Natl Acad Sci U S A. 2005 Jan 18;102(3):862-7. doi: 10.1073/pnas.0406008102. Epub 2005 Jan 10.
Siren AL, Radyushkin K, Boretius S, Kammer D, Riechers CC, Natt O, Sargin D, Watanabe T, Sperling S, Michaelis T, Price J, Meyer B, Frahm J, Ehrenreich H. Global brain atrophy after unilateral parietal lesion and its prevention by erythropoietin. Brain. 2006 Feb;129(Pt 2):480-9. doi: 10.1093/brain/awh703. Epub 2005 Dec 9.
Ehrenreich H, Hinze-Selch D, Stawicki S, Aust C, Knolle-Veentjer S, Wilms S, Heinz G, Erdag S, Jahn H, Degner D, Ritzen M, Mohr A, Wagner M, Schneider U, Bohn M, Huber M, Czernik A, Pollmacher T, Maier W, Siren AL, Klosterkotter J, Falkai P, Ruther E, Aldenhoff JB, Krampe H. Improvement of cognitive functions in chronic schizophrenic patients by recombinant human erythropoietin. Mol Psychiatry. 2007 Feb;12(2):206-20. doi: 10.1038/sj.mp.4001907. Epub 2006 Oct 10.
Ehrenreich H, Fischer B, Norra C, Schellenberger F, Stender N, Stiefel M, Siren AL, Paulus W, Nave KA, Gold R, Bartels C. Exploring recombinant human erythropoietin in chronic progressive multiple sclerosis. Brain. 2007 Oct;130(Pt 10):2577-88. doi: 10.1093/brain/awm203. Epub 2007 Aug 29.
Woywodt A, Gerdes S, Ahl B, Erdbruegger U, Haubitz M, Weissenborn K. Circulating endothelial cells and stroke: influence of stroke subtypes and changes during the course of disease. J Stroke Cerebrovasc Dis. 2012 Aug;21(6):452-8. doi: 10.1016/j.jstrokecerebrovasdis.2010.11.003.
Ehrenreich H, Weissenborn K, Prange H, Schneider D, Weimar C, Wartenberg K, Schellinger PD, Bohn M, Becker H, Wegrzyn M, Jahnig P, Herrmann M, Knauth M, Bahr M, Heide W, Wagner A, Schwab S, Reichmann H, Schwendemann G, Dengler R, Kastrup A, Bartels C; EPO Stroke Trial Group. Recombinant human erythropoietin in the treatment of acute ischemic stroke. Stroke. 2009 Dec;40(12):e647-56. doi: 10.1161/STROKEAHA.109.564872. Epub 2009 Oct 15.
Related Links
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homepage of the Max-Planck-Institute of Experimental Medicine
Other Identifiers
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"EPO Stroke Study"
Identifier Type: -
Identifier Source: secondary_id
"Ehrenreich EPO Stroke Study"
Identifier Type: -
Identifier Source: secondary_id
"Ehrenreich Study"
Identifier Type: -
Identifier Source: secondary_id
BfArM-4019639/2002
Identifier Type: -
Identifier Source: org_study_id