Mobile Stroke Unit deployment for acute stroke treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Music therapy after stroke

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• Endovascular therapy plus standard care vs standard care alone for distal and medium vessel strokes

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  Recruiting Hospital Universitari Vall d'Hebron Research Institute · Barcelona, Barcelona · NCT07843797

• Inter-Limb Transfer after Acute Stroke

  This study tests whether practicing motor skills with the affected arm helps improve movement in the other arm after an acute stroke.

  Recruiting at 2 sites University Hospital of Mont-Godinne · Yvoir, Namur and 1 other locations · NCT07822633

• Immersive Virtual Reality in Upper-Limb Rehabilitation After Stroke

  This trial tests whether adding immersive virtual reality to standard upper-limb rehabilitation helps stroke patients recover more function and quality of life.

  Recruiting Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Girona · NCT07609966

• Anakinra After Endovascular Therapy for Ischemic Stroke

  This trial tests whether giving two doses of Anakinra after successful endovascular treatment can reduce brain damage and improve outcomes in adults with acute ischemic stroke.

  Recruiting at 6 sites Phase 2 Beijing Tiantan Hospital · Beijing, Beijing Municipality and 5 other locations · NCT07423975

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.