International journal of stroke : official journal of the International Stroke Society
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Randomized Controlled Trial Multicenter Study
TESPI (Thrombolysis in Elderly Stroke Patients in Italy): a randomized controlled trial of alteplase (rt-PA) versus standard treatment in acute ischaemic stroke in patients aged more than 80 years where thrombolysis is initiated within three hours after stroke onset.
Intravenous (i.v.) thrombolysis with recombinant tissue-Plasminogen Activator (rt-PA) (alteplase) within three hours from symptom onset is the only approved treatment of pharmacological revascularization in acute ischaemic stroke. However, the current license limits the use of rt-PA to patients aged ≤80 years due to the lack of evidence of safety and efficacy of this treatment in the elderly from randomized clinical trials. This article describes the design of the Thrombolysis in Elderly Stroke Patients in Italy (TESPI) trial planned to fill the lack of controlled data on i.v. thrombolysis in this age category of stroke patients. ⋯ The primary efficacy end-point is the disability at day 90, dichotomized as a favourable outcome (modified Rankin Scale 0-2) or unfavourable outcome (modified Rankin Scale 3-6). The main primary safety end-point is symptomatic intracerebral haemorrhage defined as any hemorrhage at the 22-36 h post-treatment scan combined with neurological deterioration leading to an increase of one or more points at the National Institutes of Health Stroke Scale. The TESPI trial, with the protocol number FARM65KNKY, is registered in the European Union Drug Regulating Authorities Clinical Trials database with the number 2007-006177-88 and in the Stroke Trials Registry of the Washington University Internet Stroke Center.
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Functional outcome in acute stroke trials among others is usually measured on the modified Rankin Scale. However, new onset of depression, cognitive decline, and communication deficits alone or in combination affect more than 25% of patients. This report summarizes the findings and conclusions of a workshop by the European Stroke Organization held in February 2011 We propose that assessment of mood disorders, cognitive impairment/dementia, language or communication dysfunction, and quality of life should supplement outcome measures after acute stroke.
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Multicenter Study
Thrombolytic therapy for acute ischemic stroke after recent transient ischemic attack.
Safety and efficacy of intravenous thrombolysis in stroke patients with recent transient ischemic attack are hotly debated. Patients suffering transient ischemic attack may present with diffusion-weighted imaging lesions, and although normal computed tomography would not preclude thrombolysis, the concern is that they may be at higher risk for hemorrhage post-thrombolysis treatment. Prior ipsilateral transient ischemic attack might provide protection due to ischemic preconditioning. We assessed post-thrombolysis outcomes in stroke patients who had prior transient ischemic attack. ⋯ Transient ischemic attack preceding ischemic stroke does not appear to have a major influence on outcomes following thrombolysis. Patients with prior ipsilateral transient ischemic attack appear not to be at higher risk of bleeding complications.
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The Quality in Acute Stroke Care (QASC) was a cluster randomised control trial (CRCT) which evaluated the effectiveness of evidence-based clinical treatment protocols for the management of fever, hyperglycaemia and swallowing, in conjunction with multidisciplinary team building workshops, and a standardised interactive staff education program (collectively known as the Fever, Sugar, Swallowing (FeSS) intervention) to improve patient outcomes 90-days. We found that patients cared for in stroke units who received our intervention were 15·7% more likely to be alive and independent 90 days following their stroke. They also had significantly: fewer episodes of fever, lower mean temperatures, lower mean blood glucose levels, and better screening for swallowing difficulties.