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| ID | Type | Description | Link |
|---|---|---|---|
| "EPO Stroke Study" | |||
| "Ehrenreich EPO Stroke Study" | |||
| "Ehrenreich Study" |
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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
| Parexel | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | 50ml 0.9% NaCL |
|
| verum | Active Comparator | erythropoietin alfa 40,000 IU iv in 50ml 0.9% NaCl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human erythropoietin alfa | Drug | 40,000 IU in 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Neurological/functional outcome as measured by the Barthel Index (BI) | day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rankin Scale (mRS) responder | day 90 | |
| Barthel Index (BI) | day 30 | |
| mRS |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurologische Klinik des Städtischen Klinikums Braunschweig | Braunschweig | D-38126 | Germany | |||
| Neurologische Klink, Klinikum Bremen-Mitte |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11259643 | Background | 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. | |
| 12435860 |
| Label | URL |
|---|---|
| homepage of the Max-Planck-Institute of Experimental Medicine | View source |
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| 0.9% NaCl | Drug | 50ml 0.9% NaCl iv on 3 consecutive days, starting within 6 hours after onset of symptoms |
|
| 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 |
| Bremen |
| D-28177 |
| Germany |
| Neurologische Klinik, Allgemeines Krankenhaus Celle | Celle | D-29223 | Germany |
| Klinik und Poliklinik für Neurologie, Universitätsklinikum Carl Gustav Carus der TU Dresden | Dresden | D-01307 | Germany |
| Neurologische Klinik, Universität Erlangen-Nürnberg | Erlangen | D-91054 | Germany |
| Klinik für Neurologie, Universität Essen | Essen | D-45147 | Germany |
| Neurologische Universitätsklinik der Georg-August-Universität Goettingen | Göttingen | D-37075 | Germany |
| Neurologische Klinik, Medizinische Hochschule Hannover | Hanover | D-30625 | Germany |
| Klinik und Poliklinik für Neurologie der Universität Leipzig | Leipzig | D-04103 | Germany |
| 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. |
| 11095504 | Background | 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. |
| 11307627 | Background | 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. |
| 14530580 | Background | 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. |
| 15642952 | Background | 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. |
| 16339796 | Background | 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. |
| 17033631 | Background | 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. |
| 17728357 | Background | 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. |
| 21852153 | Derived | 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. |
| 19834012 | Derived | 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. |
| information about the German Multicenter EPO Stroke Study and previous related trials | View source |
| ID | Term |
|---|---|
| D020244 | Infarction, Middle Cerebral Artery |
| D020521 | Stroke |
| D007511 | Ischemia |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D002544 | Cerebral Infarction |
| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007238 | Infarction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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