Actively Recruiting
Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT
Led by Centre Hospitalier St Anne · Updated on 2024-02-01
450
Participants Needed
11
Research Sites
191 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier St Anne
Lead Sponsor
A
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Emergency call to SAMU or BSPP dispatch centers between 08:00 and 18:00, Monday to Friday
- Suspected acute stroke according to a dispatcher stroke identification algorithm adapted from the ROSIER scale
- Symptom onset-to-randomization time 6 hours or less
- Patient located within the predefined catchment area of the Mobile Stroke Unit
- Mobile Stroke Unit available at the time of the emergency medical service call
- Informed consent obtained after randomization at MSU arrival (intervention) or hospital arrival (control)
You will not qualify if you...
- Patient confined to more than 50% of waking hours
- Unknown or uncertain stroke onset time, such as wake-up stroke
- Medical history of epilepsy
- Recent epileptic seizure within 12 hours
- Suspicion of pregnancy
- Parturient or breastfeeding woman
- Participation in another interventional study that could affect 3-month outcomes
- Patient under guardianship or curatorship
- Patient not affiliated with French Social Security
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
AP-HP - hôpital Raymond Poincaré
Garches, France, 92380
Actively Recruiting
2
AP-HP - hôpital Bicêtre
Le Kremlin-Bicêtre, France, 94275
Actively Recruiting
3
AP-HP - hôpital Lariboisière
Paris, France, 75010
Actively Recruiting
4
AP-HP - hôpital de la Pitié-Salpêtrière
Paris, France, 75013
Actively Recruiting
5
GHU Paris psychiatrie & neurosciences
Paris, France, 75014
Actively Recruiting
6
SAMU 75 de Paris
Paris, France, 75015
Actively Recruiting
7
BSPP, Brigade des Sapeurs-Pompiers de Paris
Paris, France, 75017
Actively Recruiting
8
AP-HP - hôpital Bichat - Claude-Bernard
Paris, France, 75018
Actively Recruiting
9
Fondation Ophtalmologique Rothschild
Paris, France, 75019
Actively Recruiting
10
Hôpital Saint Joseph
Paris, France, 75674
Not Yet Recruiting
11
Hôpital Foch
Suresnes, France, 92151
Actively Recruiting
Research Team
K
Khaoussou SYLLA, MD, PhD
CONTACT
M
Malha BERRAH, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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