Title |
A pragmatic approach to sonothrombolysis in acute ischaemic stroke: the Norwegian randomised controlled sonothrombolysis in acute stroke study (NOR-SASS)
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Published in |
BMC Neurology, July 2015
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DOI | 10.1186/s12883-015-0359-4 |
Pubmed ID | |
Authors |
Aliona Nacu, Christopher E. Kvistad, Nicola Logallo, Halvor Naess, Ulrike Waje-Andreassen, Anne Hege Aamodt, Ragnar Solhoff, Christian Lund, Håkon Tobro, Ole Morten Rønning, Rolf Salvesen, Titto T. Idicula, Lars Thomassen |
Abstract |
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. 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. 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. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
India | 1 | 1% |
United States | 1 | 1% |
Unknown | 77 | 97% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 10 | 13% |
Student > Bachelor | 9 | 11% |
Other | 8 | 10% |
Student > Ph. D. Student | 6 | 8% |
Student > Doctoral Student | 6 | 8% |
Other | 18 | 23% |
Unknown | 22 | 28% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 24 | 30% |
Neuroscience | 5 | 6% |
Nursing and Health Professions | 4 | 5% |
Biochemistry, Genetics and Molecular Biology | 3 | 4% |
Pharmacology, Toxicology and Pharmaceutical Science | 3 | 4% |
Other | 13 | 16% |
Unknown | 27 | 34% |