NCT03290053

Contrast Enhanced Sonothrombolysis and Sonolysis in Stroke - a Swedish Study (CE-5S)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
DRUG	SonoVue	SonoVue-infusion over 1 hour
DRUG	Sodium chloride	Placebo
PROCEDURE	Transcranial Ultrasound	Transcranial ultrasound aimed at the blockage
PROCEDURE	Sham Transcranial Ultrasound	Placebo - machine is attached, but not active

Timeline

• Start date: 2017-11-28
• Primary completion: 2018-04-18
• Completion: 2018-04-18
• First posted: 2017-09-21
• Last updated: 2018-05-11

Locations

1 site across 1 country: Sweden