Contrast Enhanced Sonothrombolysis and Sonolysis in Stroke - a Swedish Study (CE-5S)
Status:
Terminated
Trial end date:
2018-04-18
Target enrollment:
Participant gender:
Summary
Patients with acute ischemic stroke in anterior circulation within 4,5 hours of symptom
onset, has a bone window and Trombolysis In Brain Ischemia (TIBI) <=4 in a relevant artery
eligible. Both patients receiving thrombolysis and those who do not due to contraindications
such as anticoagulation or recent surgery are enrolled, but into different study arms (CE-5S
A for thrombolysis and B for non-thrombolysis); the decision to treat with thrombolysis or
not is done according to clinical routine.
All included patients are randomized to receive transcranial ultrasound and SonoVue-infusion
or sham-ultrasound and placebo; i.e. in CE-5S A, contrast enhanced sonothrombolysis is
compared to thrombolysis and in CE-5S B, contrast enhanced sonolysis is compared with
conservative management.
Main outcome is improvement in National Institute of Health Stroke Scale (NIHSS) at 24 hours
compared to baseline. Main safety outcome is symptomatic intracerebral haemorrhage.