Safety and efficacy of sonothrombolysis for acute ischaemic stroke: a multicentre, double-blind, phase 3, randomised controlled trial

Publication date: April 2019Source: The Lancet Neurology, Volume 18, Issue 4Author(s): Andrei V Alexandrov, Martin Köhrmann, Lauri Soinne, Georgios Tsivgoulis, Andrew D Barreto, Andrew M Demchuk, Vijay K Sharma, Robert Mikulik, Keith W Muir, Gordon Brandt, John Alleman, James C Grotta, Christopher R Levi, Carlos A Molina, Maher Saqqur, Dimitris Mavridis, Theodora Psaltopoulou, Milan Vosko, Jochen B Fiebach, Pitchaiah MandavaSummaryBackgroundPulsed-wave ultrasound increases the exposure of an intracranial thrombus to alteplase (recombinant tissue plasminogen activator), potentially facilitating early reperfusion. We aimed to ascertain if a novel operator-independent transcranial ultrasound device delivering low-power high-frequency ultrasound could improve functional outcome in patients treated with alteplase after acute ischaemic stroke.MethodsWe did a multicentre, double-blind, phase 3, randomised controlled trial (CLOTBUST-ER) at 76 medical centres in 14 countries. We included patients with acute ischaemic stroke (National Institutes of Health Stroke Scale score ≥10) who received intravenous thrombolysis (alteplase bolus) within 3 h of symptom onset in North America and within 4·5 h of symptom onset in all other countries. Participants were randomly allocated (1:1) via an interactive web response system to either active ultrasound (2 MHz pulsed-wave ultrasound for 120 min [sonothrombolysis]; intervention group) or sham ultrasound (control group). Ultrasound was delivere...
Source: The Lancet Neurology - Category: Neurology Source Type: research