Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/18078
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dc.contributor.authorThomalla, Götz-
dc.contributor.authorSimonsen, Claus Z-
dc.contributor.authorBoutitie, Florent-
dc.contributor.authorAndersen, Grethe-
dc.contributor.authorBerthezene, Yves-
dc.contributor.authorCheng, Bastian-
dc.contributor.authorCheripelli, Bharath-
dc.contributor.authorCho, Tae-Hee-
dc.contributor.authorFazekas, Franz-
dc.contributor.authorFiehler, Jens-
dc.contributor.authorFord, Ian-
dc.contributor.authorGalinovic, Ivana-
dc.contributor.authorGellissen, Susanne-
dc.contributor.authorGolsari, Amir-
dc.contributor.authorGregori, Johannes-
dc.contributor.authorGünther, Matthias-
dc.contributor.authorGuibernau, Jorge-
dc.contributor.authorHäusler, Karl Georg-
dc.contributor.authorHennerici, Michael-
dc.contributor.authorKemmling, André-
dc.contributor.authorMarstrand, Jacob-
dc.contributor.authorModrau, Boris-
dc.contributor.authorNeeb, Lars-
dc.contributor.authorPerez de la Ossa, Natalia-
dc.contributor.authorPuig, Josep-
dc.contributor.authorRingleb, Peter-
dc.contributor.authorRoy, Pascal-
dc.contributor.authorScheel, Enno-
dc.contributor.authorSchonewille, Wouter-
dc.contributor.authorSerena, Joaquin-
dc.contributor.authorSunaert, Stefan-
dc.contributor.authorVillringer, Kersten-
dc.contributor.authorWouters, Anke-
dc.contributor.authorThijs, Vincent N-
dc.contributor.authorEbinger, Martin-
dc.contributor.authorEndres, Matthias-
dc.contributor.authorFiebach, Jochen B-
dc.contributor.authorLemmens, Robin-
dc.contributor.authorMuir, Keith W-
dc.contributor.authorNighoghossian, Norbert-
dc.contributor.authorPedraza, Salvador-
dc.contributor.authorGerloff, Christian-
dc.date2018-05-16-
dc.date.accessioned2018-07-10T06:37:39Z-
dc.date.available2018-07-10T06:37:39Z-
dc.date.issued2018-08-16-
dc.identifier.citationThe New England Journal of Medicine 2018; 379(7): 611-622-
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/18078-
dc.description.abstractBackground Under current guidelines, intravenous thrombolysis is used to treat acute stroke only if it can be ascertained that the time since the onset of symptoms was less than 4.5 hours. We sought to determine whether patients with stroke with an unknown time of onset and features suggesting recent cerebral infarction on magnetic resonance imaging (MRI) would benefit from thrombolysis with the use of intravenous alteplase. Methods In a multicenter trial, we randomly assigned patients who had an unknown time of onset of stroke to receive either intravenous alteplase or placebo. All the patients had an ischemic lesion that was visible on MRI diffusion-weighted imaging but no parenchymal hyperintensity on fluid-attenuated inversion recovery (FLAIR), which indicated that the stroke had occurred approximately within the previous 4.5 hours. We excluded patients for whom thrombectomy was planned. The primary end point was favorable outcome, as defined by a score of 0 or 1 on the modified Rankin scale of neurologic disability (which ranges from 0 [no symptoms] to 6 [death]) at 90 days. A secondary outcome was the likelihood that alteplase would lead to lower ordinal scores on the modified Rankin scale than would placebo (shift analysis). Results The trial was stopped early owing to cessation of funding after the enrollment of 503 of an anticipated 800 patients. Of these patients, 254 were randomly assigned to receive alteplase and 249 to receive placebo. A favorable outcome at 90 days was reported in 131 of 246 patients (53.3%) in the alteplase group and in 102 of 244 patients (41.8%) in the placebo group (adjusted odds ratio, 1.61; 95% confidence interval [CI], 1.09 to 2.36; P=0.02). The median score on the modified Rankin scale at 90 days was 1 in the alteplase group and 2 in the placebo group (adjusted common odds ratio, 1.62; 95% CI, 1.17 to 2.23; P=0.003). There were 10 deaths (4.1%) in the alteplase group and 3 (1.2%) in the placebo group (odds ratio, 3.38; 95% CI, 0.92 to 12.52; P=0.07). The rate of symptomatic intracranial hemorrhage was 2.0% in the alteplase group and 0.4% in the placebo group (odds ratio, 4.95; 95% CI, 0.57 to 42.87; P=0.15). Conclusions In patients with acute stroke with an unknown time of onset, intravenous alteplase guided by a mismatch between diffusion-weighted imaging and FLAIR in the region of ischemia resulted in a significantly better functional outcome and numerically more intracranial hemorrhages than placebo at 90 days. (Funded by the European Union Seventh Framework Program; WAKE-UP ClinicalTrials.gov number, NCT01525290; and EudraCT number, 2011-005906-32 .).-
dc.language.isoeng-
dc.titleMRI-Guided Thrombolysis for Stroke with Unknown Time of Onset.-
dc.typeJournal Article-
dc.identifier.journaltitleThe New England Journal of Medicine-
dc.identifier.affiliationKlinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, Universitätsklinikum Hamburg-Eppendorf, Germany-
dc.identifier.affiliationDepartment of Diagnostic and Interventional Neuroradiology, University Medical Center Hamburg-Eppendorf, Germany-
dc.identifier.affiliationZytoService Deutschland (E.S.), Hamburg, Universitätsklinik für Neurologie, Medizinische Universität Graz, Graz, Germany-
dc.identifier.affiliationCentrum für Schlaganfallforschung Berlin, Germany-
dc.identifier.affiliationKlinik und Hochschulambulanz für Neurologie, Germany-
dc.identifier.affiliationCharité-Universitätsmedizin Berlin, Germany-
dc.identifier.affiliationNeurologie der Rehaklinik Medical Park Humboldtmühle, Germany-
dc.identifier.affiliationBerlin, Mediri, Germany-
dc.identifier.affiliationDepartment of Neurology, Medical Faculty Mannheim, University of Heidelberg, Germany-
dc.identifier.affiliationNeurologische Klinik, Universitätsklinikum Heidelberg, Germany-
dc.identifier.affiliationHeidelberg, Fraunhofer MEVIS and University of Bremen, Bremen, Germany-
dc.identifier.affiliationInstitut für Neuroradiologie, Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Lübeck, Germany-
dc.identifier.affiliationDepartment of Neurology, Aarhus University Hospital, Aarhus, Denmark-
dc.identifier.affiliationDepartment of Neurology, Bispebjerg Hospital, Copenhagen University Hospital, Copenhagen, Denmark-
dc.identifier.affiliationDepartment of Neurology, Stroke Unit, Aalborg University Hospital, Aalborg, Denmark-
dc.identifier.affiliationHospices Civils de Lyon, Service de Biostatistique, France-
dc.identifier.affiliationNeuroradiology Department, Neurological Hospital, University Lyon, France-
dc.identifier.affiliationDepartment of Stroke Medicine, Université Claude Bernard Lyon 1, France-
dc.identifier.affiliationHospices Civils de Lyon, Lyon, France-
dc.identifier.affiliationUniversité Lyon 1 and Centre National de la Recherche Scientifique, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France-
dc.identifier.affiliationInstitute of Neuroscience and Psychology and the Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom-
dc.identifier.affiliationFundació Salut Empordà Hospital, Figueres, Spain-
dc.identifier.affiliationStroke Unit, Department of Neurosciences, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain-
dc.identifier.affiliationDepartment of Radiology and the Stroke Unit, Hospital Universitari Doctor Josep Trueta, Institut d'Investigació Biomèdica de Girona, Girona, Spain-
dc.identifier.affiliationDepartment of Neurology, St. Antonius Hospital, Nieuwegein, Netherlands-
dc.identifier.affiliationUniversity Medical Center Utrecht, Utrecht, Netherlands-
dc.identifier.affiliationDepartment of Imaging and Pathology, University of Leuven, Belgium-
dc.identifier.affiliationDepartment of Neurology, University Hospitals Leuven, Belgium-
dc.identifier.affiliationKU Leuven-University of Leuven, Department of Neurosciences, Experimental Neurology, and the VIB-KU Leuven Center for Brain and Disease Research, Laboratory of Neurobiology, Leuven, Belgium-
dc.identifier.affiliationThe Florey Institute of Neuroscience and Mental Health, Heidelberg, Victoria, Australia-
dc.identifier.doi10.1056/NEJMoa1804355-
dc.identifier.orcid0000-0002-4785-1449-
dc.identifier.orcid0000-0002-6614-8417-
dc.identifier.pubmedid29766770-
dc.type.austinJournal Article-
local.name.researcherThijs, Vincent N
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.languageiso639-1en-
item.openairetypeJournal Article-
crisitem.author.deptNeurology-
crisitem.author.deptThe Florey Institute of Neuroscience and Mental Health-
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