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dc.contributor.authorDagonnier, Marieen
dc.contributor.authorHowells, David Williamen
dc.contributor.authorDonnan, Geoffrey Aen
dc.contributor.authorDewey, Helen Men
dc.identifier.citationJournal of Clinical Neuroscience 2014; 21(7): 1215-9en
dc.description.abstractTo increase the percentage of acute stroke patients benefiting from thrombolysis, the utility of expanding the time window of treatment beyond 4.5 hours after stroke onset needs to be investigated. We aimed to identify the target population and the challenges of recruitment of patients for the time window beyond 4.5 hours. Extending the time for Thrombolysis in Emergency Neurological Deficits (EXTEND), a multicentre randomised controlled trial testing the efficacy of thrombolytic therapy in patients with clinically significant ischaemic penumbra between 4.5 to 9 hours after stroke onset, was used as a model to evaluate inclusion and exclusion criteria for late thrombolysis trials. Data from all stroke patients admitted to Austin Health over a 1 year period were retrospectively analysed. Case notes were examined to determine potential trial eligibility. Of 556 patients assessed, 95 (17%) presented during the EXTEND time window. Sixty-seven of these (70.5%) were wake-up strokes (WUS) and 28 (29.5%) arrived between 4.5 and 9 hours after symptoms onset. At least one exclusion criterion was found for 78 (82%) of them. Hence, 17 (3%) patients arrived within an appropriate time frame for the study without any exclusion criteria. Most of these (13) arrived outside routine MRI hours. The number of patients recruited would have increased more than three-fold if imaging had been available 24 hours, 7 days a week. A significant proportion (17%) of ischaemic stroke patients presented between 4.5 and 9 hours after stroke onset. The majority of these were WUS. The major challenge identified for patient recruitment was imaging availability.en
dc.subject.otherClinical trialsen
dc.subject.otherNervous System Diseases.drug therapy.etiologyen
dc.subject.otherPatient Selectionen
dc.subject.otherRandomized Controlled Trials as Topicen
dc.subject.otherRetrospective Studiesen
dc.subject.otherStroke.complications.drug therapyen
dc.subject.otherThrombolytic Therapy.methodsen
dc.subject.otherTime Factorsen
dc.subject.otherTissue Plasminogen Activator.therapeutic useen
dc.titleRecruitment to trials of late thrombolysis: lessons from the EXTEND study.en
dc.typeJournal Articleen
dc.identifier.journaltitleJournal of Clinical Neuroscienceen
dc.identifier.affiliationNational Stroke Research Institute, The Florey Institute for Neurosciences and Mental Health, Melbourne Brain Centre, Austin Campus, 245 Burgundy Street, Heidelberg, VIC 3084, Australiaen
dc.identifier.affiliationDepartment of Neurology, Austin Health, Heidelberg, VIC, Australiaen
dc.identifier.affiliationUniversity of Melbourne, Melbourne, VIC, Australiaen
dc.type.austinJournal Articleen
item.openairetypeJournal Article-
item.fulltextNo Fulltext-
item.languageiso639-1en- Florey Institute of Neuroscience and Mental Health-
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