Comparison of Mobile Stroke Unit With Usual Care for Acute Ischemic Stroke Management: A Systematic Review and Meta-analysis.
Guillaume Turc, Melika Hadziahmetovic, Silke Walter...
https://pubmed.ncbi.nlm.nih.gov/35129584Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05649670
Prehospital Initiation of Reperfusion Therapy for Acute Ischemic Stroke: Randomized Medico-economic Evaluation of a Mobile Stroke Unit
Led by Centre Hospitalier St Anne · Updated on 2024-02-01
450
Participants Needed
11
Research Sites
34 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
Researchers are evaluating the use of Mobile Stroke Units (MSUs), specialized ambulances equipped with CT scanners, for prehospital initiation of intravenous thrombolysis (IVT) in patients with acute ischemic stroke. This trial compares MSU deployment to standard care and aims to assess both clinical outcomes and cost-utility, particularly focusing on time to treatment and functional recovery at 3 months. The study involves 450 patients in France with confirmed acute ischemic stroke within 6 hours of symptom onset, followed for 3 months. Participants are randomly assigned to either receive care from the MSU plus a conventional ambulance or from a conventional ambulance alone. The MSU group benefits from on-site CT imaging including intracranial CT angiography, enabling earlier IVT and better triage for mechanical thrombectomy eligibility. The trial is open-label but includes blinded assessment of outcomes. Recruitment occurs over 3 years, with follow-up assessments at 3 months after treatment. During the study, researchers collect data on treatment timing, clinical outcomes including the Modified Rankin Scale at 3 months, and health economics. They track the incremental cost-utility ratio over 3 months and project it over a lifetime horizon. Safety monitoring includes recording deaths within 7 and 90 days, symptomatic intracranial hemorrhage, and other relevant events. Participants provide informed consent after randomization, and outcomes related to IVT and mechanical thrombectomy use and timing are closely evaluated.
CONDITIONS
Brief Title
Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Emergency call to SAMU or BSPP EMS dispatch centers between 08:00 and 18:00, Monday to Friday
- Suspected acute stroke based on dispatcher stroke identification algorithm adapted from the ROSIER scale
- Symptom onset to randomization time of 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 EMS call
- Informed consent obtained after randomization
You will not qualify if you...
- Patient confined to more than 50% of waking hours
- Unknown or uncertain symptom onset time (e.g., wake-up stroke)
- Medical history of epilepsy
- Recent epileptic seizure within 12 hours
- Suspected pregnancy
- Parturient or breastfeeding woman
- Participation in another interventional study affecting the 3-month Modified Rankin Scale
- Patient under guardianship or curatorship
- Patient not affiliated with French Social Security
AI-Screening
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Your Study Journey
Screening
Duration - Up to 6 hours from symptom onset
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (pre-hospital or at hospital arrival)
Treatment
Duration - Up to 24 hours from symptom onset
Participants receive either prehospital reperfusion therapy via a Mobile Stroke Unit or standard care with conventional ambulance transport, including imaging and treatment initiation.
Initial treatment occurs during emergency response and hospital admission
Follow-up
Duration - 3 months
Participants are followed for clinical outcomes and safety assessments including functional status and survival.
Follow-up visits or assessments at approximately 3 months after treatment
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
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Research Team
K
Khaoussou SYLLA, MD, PhD
M
Malha BERRAH, MSc
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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