NCT05649670

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

Prehospital Initiation of Reperfusion Therapy for Acute Ischemic Stroke: Randomized Medico-economic Evaluation of a Mobile Stroke Unit.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Centre Hospitalier St Anne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

ASPHALT is an academic-driven open-label randomized controlled trial of Mobile Stroke Unit (MSU) deployment versus standard care in France, with blinded assessment of efficacy endpoints. 450 patients with confirmed acute ischemic stroke will be recruited over a 3-year period, with 3-month follow-up.

Detailed description

Instead of the traditional approach of waiting until the patient arrives at the hospital to perform brain imaging and start reperfusion therapies, mobile stroke units (MSUs; ambulances equipped with a CT scanner) now allow pre-hospital initiation of intravenous thrombolysis (IVT). Two large non-randomized clinical trials (B\_PROUD \& BEST-MSU) have recently shown that MSU use leads to improved functional outcomes at 3 months in specific settings. However, MSUs have been criticized because of their cost and a lack of evidence of a significant reduction in the time between symptom onset and mechanical thrombectomy, which is the cornerstone of treatment of patients with large vessel occlusion. We hypothesized that compared to usual care, the deployment of a MSU would result in an incremental cost-utility ratio ≤50,000 euros per QALY in the lifetime horizon, even in an area with many thrombectomy-capable centers.. Academic-driven open-label randomized controlled trial of Mobile Stroke Unit (MSU) deployment versus standard care in France, with blinded assessment of efficacy endpoints. Randomization will be performed on an individual patient basis (randomization of MSU deployment at dispatch). 450 patients with confirmed acute ischemic stroke (emergency call ≤6 hours after onset) will be recruited over a 3-year period, with 3-month follow-up. Costs and clinical outcomes will be collected prospectively during the study period and used to extrapolate the incremental cost-utility ratio over a lifetime horizon.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
OTHER	Mobile Stroke Unit deployment	Deployment of an MSU + conventional ambulance, allowing prehospital CT-scan imaging with intracranial CT angiography. This will allow prehospital intravenous thrombolysis and optimal triage (i.e. accurate identification of patients with large vessel occlusion, who are eligible for mechanical thrombectomy).

Timeline

• Start date: 2023-10-16
• Primary completion: 2026-10-16
• Completion: 2027-06-16
• First posted: 2022-12-14
• Last updated: 2024-02-01

Locations

11 sites across 1 country: France