Evaluating Mobile Stroke Unit Use vs Standard Care for Early Treatment of Acute Ischemic Stroke in France

What this Trial Is About

Researchers are evaluating the use of Mobile Stroke Units MSUs, specialized ambulances equipped with CT scanners, for prehospital initiation of intravenous thrombolysis IVT in patients with acute ischemic stroke. This trial compares MSU deployment to standard care and aims to assess both clinical outcomes and cost-utility, particularly focusing on time to treatment and functional recovery at 3 months. The study involves 450 patients in France with confirmed acute ischemic stroke within 6 hours of symptom onset, followed for 3 months. Participants are randomly assigned to either receive care from the MSU plus a conventional ambulance or from a conventional ambulance alone. The MSU group benefits from on-site CT imaging including intracranial CT angiography, enabling earlier IVT and better triage for mechanical thrombectomy eligibility. The trial is open-label but includes blinded assessment of outcomes. Recruitment occurs over 3 years, with follow-up assessments at 3 months after treatment. During the study, researchers collect data on treatment timing, clinical outcomes including the Modified Rankin Scale at 3 months, and health economics. They track the incremental cost-utility ratio over 3 months and project it over a lifetime horizon. Safety monitoring includes recording deaths within 7 and 90 days, symptomatic intracranial hemorrhage, and other relevant events. Participants provide informed consent after randomization, and outcomes related to IVT and mechanical thrombectomy use and timing are closely evaluated.

Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT