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).
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Incremental Cost-Utility Ratio (ICUR) — 3 months ICUR in the lifetime horizon, based on extrapolated results of the Modified Rankin Scale (mRS) at 3 months and incremental costs prospectively collected during the first 3 months
Key secondary outcome: Modified Rankin Scale (mRS) at 3 months — 90 +/- 14 days Modified Rankin scale, assessed in a blinded fashion (range, 0 to 6, with 0 indicating no disability, 3 indicating moderate disability, and 6 indicating death)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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