Prehospital Initiation of Reperfusion Therapy for Acute Ischemic Stroke: Randomized Medico-economic Evaluation of a Mobile Stroke Unit.

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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))

Locations
Other Locations
France
AP-HP - hôpital Raymond Poincaré
RECRUITING
Garches
AP-HP - hôpital Bicêtre
RECRUITING
Le Kremlin-bicêtre
AP-HP - hôpital Bichat - Claude-Bernard
RECRUITING
Paris
AP-HP - hôpital de la Pitié-Salpêtrière
RECRUITING
Paris
AP-HP - hôpital Lariboisière
RECRUITING
Paris
BSPP, Brigade des Sapeurs-Pompiers de Paris
RECRUITING
Paris
Fondation Ophtalmologique Rothschild
RECRUITING
Paris
GHU Paris psychiatrie & neurosciences
RECRUITING
Paris
Hôpital Saint Joseph
NOT_YET_RECRUITING
Paris
SAMU 75 de Paris
RECRUITING
Paris
Hôpital Foch
RECRUITING
Suresnes
Contact Information
Primary
Khaoussou SYLLA, MD, PhD
k.sylla@ghu-paris.fr
+33 (01) 45 65 76 78
Backup
Malha BERRAH, MSc
malha.berrah@aphp.fr
+33 (0)1 56 09 58 22
Time Frame
Start Date: 2023-10-16
Estimated Completion Date: 2027-06-16
Participants
Target number of participants: 450
Treatments
Experimental: Intervention (MSU)
Deployment of MSU + conventional ambulance
No_intervention: Control (usual care)
Deployment of conventional ambulance
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier St Anne
Collaborators: Assistance Publique - Hôpitaux de Paris, Ministry of Health, France

This content was sourced from clinicaltrials.gov

Similar Clinical Trials