Mobile Stroke Unit deployment for acute stroke treatment
Prehospital Initiation of Reperfusion Therapy for Acute Ischemic Stroke: Randomized Medico-economic Evaluation of a Mobile Stroke Unit.
This study is testing if using Mobile Stroke Units to start treatment for stroke patients before they reach the hospital can help them recover better than the usual care they receive.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier St Anne Academic / other |
| Locations | 11 sites (Garches and 10 other locations) |
| Trial ID | NCT05649670 on ClinicalTrials.gov |
What this trial studies
The ASPHALT trial is an open-label randomized controlled trial comparing the use of Mobile Stroke Units (MSUs) to standard care for patients with acute ischemic stroke in France. The study aims to determine if pre-hospital initiation of intravenous thrombolysis via MSUs can improve patient outcomes compared to traditional hospital-based treatment. A total of 450 patients will be recruited over three years, with a focus on those who call emergency services within six hours of symptom onset. The trial will assess both clinical outcomes and cost-effectiveness of the MSU approach.
Who should consider this trial
Good fit: Ideal candidates are adults who have experienced symptoms of acute ischemic stroke and can call emergency services within six hours of onset.
Not a fit: Patients with unknown onset times, severe disabilities, or certain medical conditions such as recent seizures or pregnancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved functional outcomes for stroke patients by reducing treatment delays.
How similar studies have performed: Previous non-randomized studies have shown that Mobile Stroke Units can improve outcomes, but this trial aims to provide more definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Emergency call to one of the two following emergency medical service (EMS) dispatch centers : SAMU (Service d'Aide Médicale Urgente) or BSPP (Brigade des Sapeurs Pompiers de Paris), between 08:00 and 18:00, 5 days a week (Monday to Friday). * Suspected acute stroke according to a dispatcher stroke identification algorithm, adapted from the ROSIER scale * Symptom onset-to-randomization time ≤ 6h * Patient located within the predefined catchment area of the MSU * MSU available at the time of the EMS call * Informed consent (as approved by the ethics committee, informed consent will be obtained after randomization: at the arrival of the MSU (intervention group), or at hospital arrival (control group)) Exclusion Criteria: * Patient confined to be more than 50% of waking hours * Unknown or uncertain onset time (e.g. wake-up stroke) * Medical history of epilepsy * Recent epileptic seizure (\<12 hrs) * Suspicion of pregnancy * Parturient or breastfeeding woman * Patient already participating in another interventional study, which could influence the mRS at 3 months. * Patient under guardianship or curatorship * Patient not affiliated to French Social Security
Where this trial is running
Garches and 10 other locations
- AP-HP - hôpital Raymond Poincaré — Garches, France (Recruiting)
- AP-HP - hôpital Bicêtre — Le Kremlin-Bicêtre, France (Recruiting)
- AP-HP - hôpital Lariboisière — Paris, France (Recruiting)
- AP-HP - hôpital de la Pitié-Salpêtrière — Paris, France (Recruiting)
- GHU Paris psychiatrie & neurosciences — Paris, France (Recruiting)
- SAMU 75 de Paris — Paris, France (Recruiting)
- BSPP, Brigade des Sapeurs-Pompiers de Paris — Paris, France (Recruiting)
- AP-HP - hôpital Bichat - Claude-Bernard — Paris, France (Recruiting)
- Fondation Ophtalmologique Rothschild — Paris, France (Recruiting)
- Hôpital Saint Joseph — Paris, France (Not_yet_recruiting)
- Hôpital Foch — Suresnes, France (Recruiting)
Study contacts
- Principal investigator: Guillaume TURC, MD, PhD — GHU Paris Psychiatrie et Neurosciences
- Study coordinator: Khaoussou SYLLA, MD, PhD
- Email: k.sylla@ghu-paris.fr
- Phone: +33 (01) 45 65 76 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.