dc.contributor.author | Nacu, Aliona | en_US |
dc.contributor.author | Kvistad, Christopher Elnan | en_US |
dc.contributor.author | Logallo, Nicola | en_US |
dc.contributor.author | Næss, Halvor | en_US |
dc.contributor.author | Waje-Andreassen, Ulrike | en_US |
dc.contributor.author | Aamodt, Anne Hege | en_US |
dc.contributor.author | Solhoff, Ragnar | en_US |
dc.contributor.author | Lund, Christian | en_US |
dc.contributor.author | Tobro, Håkon | en_US |
dc.contributor.author | Rønning, Ole Morten | en_US |
dc.contributor.author | Salvesen, Rolf | en_US |
dc.contributor.author | Idicula, Titto | en_US |
dc.contributor.author | Thomassen, Lars | en_US |
dc.date.accessioned | 2016-03-21T09:57:34Z | |
dc.date.available | 2016-03-21T09:57:34Z | |
dc.date.issued | 2015-07-11 | |
dc.Published | BMC Neurology 2015, 15:110 | eng |
dc.identifier.issn | 1471-2377 | |
dc.identifier.uri | https://hdl.handle.net/1956/11716 | |
dc.description.abstract | Background: Ultrasound accelerates thrombolysis with tPA (sonothrombolysis). Ultrasound in the absence of tPA also accelerates clot break-up (sonolysis). Adding intravenous gaseous microbubbles may potentiate the effect of ultrasound in both sonothrombolysis and sonolysis. The Norwegian Sonothrombolysis in Acute Stroke Study aims in a pragmatic approach to assess the effect and safety of contrast enhanced ultrasound treatment in unselected acute ischaemic stroke patients. Methods/Design: Acute ischaemic stroke patients ≥18 years, with or without visible arterial occlusion on computed tomography angiography (CTA) and treatable ≤ 4½ hours after symptom onset, are included in NOR-SASS. NOR-SASS is superimposed on a separate trial randomising patients with acute ischemic stroke to either tenecteplase or alteplase (The Norwegian Tenecteplase Stroke Trial NOR-TEST). The NOR-SASS trial has two arms: 1) the thrombolysis-arms (NOR-SASS A and B) includes patients given intravenous thrombolysis (tenecteplase or alteplase), and 2) the no-thrombolysis-arm (NOR-SASS C) includes patients with contraindications to thrombolysis. First step randomisation of NOR-SASS A is embedded in NOR-TEST as a 1:1 randomisation to either tenecteplase or alteplase. Second step NOR-SASS randomisation is 1:1 to either contrast enhanced sonothrombolysis (CEST) or sham CEST. Randomisation in NOR-SASS B (routine alteplase group) is 1:1 to either CEST or sham CEST. Randomisation of NOR-SASS C is 1:1 to either contrast enhanced sonolysis (CES) or sham CES. Ultrasound is given for one hour using a 2-MHz pulsed-wave diagnostic ultrasound probe. Microbubble contrast (SonoVue®) is given as a continuous infusion for ~30 min. Recanalisation is assessed at 60 min after start of CEST/CES. Magnetic resonance imaging and angiography is performed after 24 h of stroke onset. Primary study endpoints are 1) major neurological improvement measured with NIHSS score at 24 h and 2) favourable functional outcome defined as mRS 0–1 at 90 days. Discussion: NOR-SASS is the first randomised controlled trial designed to test the superiority of contrast enhanced ultrasound treatment given ≤4½ hours after stroke onset in an unselected acute ischaemic stroke population eligible or not eligible for intravenous thrombolysis, with or without a defined arterial occlusion on CTA. If a positive effect and safety can be proven, contrast enhanced ultrasound treatment will be an option for all acute ischaemic stroke patients. EudraCT No 201200032341; www.clinicaltrials.gov NCT01949961. | en_US |
dc.language.iso | eng | eng |
dc.publisher | BioMed Central | eng |
dc.rights | Attribution CC BY | eng |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0 | eng |
dc.subject | Randomised controlled trial | eng |
dc.subject | Acute ischemic stroke | eng |
dc.subject | Arterial occlusion | eng |
dc.subject | Contrast | eng |
dc.subject | Recanalisation | eng |
dc.subject | Outcome | eng |
dc.subject | Safety | eng |
dc.subject | Sonolysis | eng |
dc.subject | Sonothrombolysis | eng |
dc.subject | Thrombolysis | eng |
dc.subject | Transcranial ultrasound | eng |
dc.title | A pragmatic approach to sonothrombolysis in acute ischaemic stroke: The Norwegian randomised controlled sonothrombolysis in acute stroke study (NOR-SASS) | en_US |
dc.type | Peer reviewed | |
dc.type | Journal article | |
dc.date.updated | 2015-11-09T14:05:42Z | |
dc.description.version | publishedVersion | en_US |
dc.rights.holder | Copyright 2015 The Authors | |
dc.identifier.doi | https://doi.org/10.1186/s12883-015-0359-4 | |
dc.identifier.cristin | 1258428 | |
dc.subject.nsi | VDP::Medisinske fag: 700::Klinisk medisinske fag: 750::Nevrologi: 752 | |
dc.subject.nsi | VDP::Midical sciences: 700::Clinical medical sciences: 750::Neurology: 752 | |