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Verfasst von:Thomalla, Götz [VerfasserIn]   i
 Günther, Matthias [VerfasserIn]   i
 Hennerici, Michael G. [VerfasserIn]   i
 Ringleb, Peter A. [VerfasserIn]   i
Titel:MRI-Guided thrombolysis for stroke with unknown time of onset
Verf.angabe:Götz Thomalla, Claus Z. Simonsen, Florent Boutitie, Grethe Andersen, Yves Berthezene, Bastian Cheng, Bharath Cheripelli, Tae-Hee Cho, Franz Fazekas, Jens Fiehler, Ian Ford, Ivana Galinovic, Susanne Gellissen, Amir Golsari, Johannes Gregori, Matthias Günther, Jorge Guibernau, Karl Georg Häusler, Michael Hennerici, André Kemmling, Jacob Marstrand, Boris Modrau, Lars Neeb, Natalia Perez de la Ossa, Josep Puig, Peter Ringleb, Pascal Roy, Enno Scheel, Wouter Schonewille, Joaquin Serena, Stefan Sunaert, Kersten Villringer, Anke Wouters, Vincent Thijs, Martin Ebinger, Matthias Endres, Jochen B. Fiebach, Robin Lemmens, Keith W. Muir, Norbert Nighoghossian, Salvador Pedraza, and Christian Gerloff
E-Jahr:2018
Jahr:August 16, 2018
Umfang:12 S.
Fussnoten:Gesehen am 06.08.2019
Titel Quelle:Enthalten in: The New England journal of medicine
Ort Quelle:Waltham, Mass. : MMS, 1928
Jahr Quelle:2018
Band/Heft Quelle:379(2018), 7, Seite 611-622
ISSN Quelle:1533-4406
Abstract:BACKGROUND 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.)
DOI:doi:10.1056/NEJMoa1804355
URL:Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.

Volltext: https://doi.org/10.1056/NEJMoa1804355
 Volltext: http://www.nejm.org/doi/10.1056/NEJMoa1804355
 DOI: https://doi.org/10.1056/NEJMoa1804355
Datenträger:Online-Ressource
Sprache:eng
K10plus-PPN:1670636232
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