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RecruitingNot ApplicableNCT05649670

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.

Sponsor

Centre Hospitalier St Anne

Enrollment

450 participants

Start Date

Oct 16, 2023

Study Type

INTERVENTIONAL

Conditions

Stroke, Acute

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria9

  • 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

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Interventions

OTHERMobile 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).

Locations(11)

AP-HP - hôpital Raymond Poincaré

Garches, France

AP-HP - hôpital Bicêtre

Le Kremlin-Bicêtre, France

AP-HP - hôpital Lariboisière

Paris, France

AP-HP - hôpital de la Pitié-Salpêtrière

Paris, France

GHU Paris psychiatrie & neurosciences

Paris, France

SAMU 75 de Paris

Paris, France

BSPP, Brigade des Sapeurs-Pompiers de Paris

Paris, France

AP-HP - hôpital Bichat - Claude-Bernard

Paris, France

Fondation Ophtalmologique Rothschild

Paris, France

Hôpital Saint Joseph

Paris, France

Hôpital Foch

Suresnes, France

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