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2015 ; 15
(ä): 110
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A pragmatic approach to sonothrombolysis in acute ischaemic stroke: the Norwegian
randomised controlled sonothrombolysis in acute stroke study (NOR-SASS)
#MMPMID26162826
Nacu A
; Kvistad CE
; Logallo N
; Naess H
; Waje-Andreassen U
; Aamodt AH
; Solhoff R
; Lund C
; Tobro H
; Rønning OM
; Salvesen R
; Idicula TT
; Thomassen L
BMC Neurol
2015[Jul]; 15
(ä): 110
PMID26162826
show ga
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 ? 4(½) 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 ? 4(½)?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.
|Brain Ischemia/*therapy
[MESH]
|Combined Modality Therapy
[MESH]
|Contrast Media/administration & dosage
[MESH]
|Fibrinolytic Agents/*therapeutic use
[MESH]
|Humans
[MESH]
|Microbubbles
[MESH]
|Stroke/*therapy
[MESH]
|Tenecteplase
[MESH]
|Tissue Plasminogen Activator/therapeutic use
[MESH]