Tests a mobile stroke unit for treating acute ischemic stroke sooner
Compares a mobile stroke unit with standard care in adults with acute ischemic stroke.
Plain-language title generated from the registry record
Registry title: Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT
Key facts
- Where
- Garches, Le Kremlin-Bicêtre, Paris, and Suresnes, FranceSee the 11 sites
Where in France
- AP-HP - hôpital Raymond PoincaréGarches, FranceTaking people
- AP-HP Hopital BicetreLe Kremlin-Bicêtre, FranceTaking people
- AP-HP Hôpital Bichat Claude-BernardParis, FranceTaking people
- AP-HP Hopital LariboisiereParis, FranceTaking people
- AP-HP, Hôpital de la Pitié SalpêtrièreParis, FranceTaking people
- BSPP, Brigade des Sapeurs-Pompiers de ParisParis, FranceTaking people
- Fondation Ophtalmologique RothschildParis, FranceTaking people
- GHU Paris Psychiatrie & NeurosciencesParis, FranceTaking people
- Hopital Saint JosephParis, FranceNot yet recruiting
- SAMU 75 de ParisParis, FranceTaking people
- Hopital FochSuresnes, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre Hospitalier St Anne
- Trial code
- NCT05649670
- Record updated
- 1 February 2024
- Original description
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.Read full original descriptionShow less
Prehospital Initiation of Reperfusion Therapy for Acute Ischemic Stroke: Randomized Medico-economic Evaluation of a Mobile Stroke Unit.
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.
Inclusion: 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: Unknown or uncertain onset time (e.g. wake-up stroke); Medical history of epilepsy; Recent epileptic seizure (<12 hrs); Patient confined to be more than 50% of waking hours; 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.