Clinical trial NCT05649670: Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT
Official title: Prehospital Initiation of Reperfusion Therapy for Acute Ischemic Stroke: Randomized Medico-economic Evaluation of a Mobile Stroke Unit.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke, Acute
Keywords: Mobile Stroke Unit
MSU
Intravenous thrombolysis
Emergency Medical Service
Mechanical thrombectomy
Cost-utility
Cost-effectiveness
Lead sponsor: Centre Hospitalier St Anne
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
name: Ministry of Health, France
First posted: 2022-12-14
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial, PROBE design
Primary purpose: TREATMENT

Brief 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.

Detailed description: Instead of the traditional approach of waiting until the patient arrives at the hospital to perform brain imaging and start reperfusion therapies, mobile stroke units (MSUs; ambulances equipped with a CT scanner) now allow pre-hospital initiation of intravenous thrombolysis (IVT). Two large non-randomized clinical trials (B_PROUD \& BEST-MSU) have recently shown that MSU use leads to improved functional outcomes at 3 months in specific settings. However, MSUs have been criticized because of their cost and a lack of evidence of a significant reduction in the time between symptom onset and mechanical thrombectomy, which is the cornerstone of treatment of patients with large vessel occlusion.

We hypothesized that compared to usual care, the deployment of a MSU would result in an incremental cost-utility ratio ≤50,000 euros per QALY in the lifetime horizon, even in an area with many thrombectomy-capable centers..

Academic-driven open-label randomized controlled trial of Mobile Stroke Unit (MSU) deployment versus standard care in France, with blinded assessment of efficacy endpoints. Randomization will be performed on an individual patient basis (randomization of MSU deployment at dispatch). 450 patients with confirmed acute ischemic stroke (emergency call ≤6 hours after onset) will be recruited over a 3-year period, with 3-month follow-up. Costs and clinical outcomes will be collected prospectively during the study period and used to extrapolate the incremental cost-utility ratio over a lifetime horizon.

Eligibility criteria: 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 outcomes:
measure: Incremental Cost-Utility Ratio (ICUR)
timeFrame: 3 months
measure: Key secondary outcome: Modified Rankin Scale (mRS) at 3 months
timeFrame: 90 +/- 14 days
Secondary outcomes:
measure: ICUR at 3 months
timeFrame: 90 +/- 14 days
measure: ICUR at 5 years
timeFrame: 5 years
measure: Time from symptom onset to intravenous thrombolysis (IVT)
timeFrame: up to 4.5 hours from symptom onset
measure: Time from symptom onset to mechanical thrombectomy (MT)
timeFrame: up to 24 hours from symptom onset
measure: Time from alarm to IVT
timeFrame: up to 4.5 hours from symptom onset
measure: Time from alarm to MT
timeFrame: up to 24 hours from symptom onset
measure: Death within 3 months after randomization
timeFrame: Within 90 days after randomization
measure: Death within 7 days after randomization
timeFrame: Within 7 days after randomization
measure: Proportion of ischemic stroke patients treated with IVT
timeFrame: up to 4.5 hours from symptom onset
measure: Proportion of ischemic stroke patients with MT
timeFrame: up to 24 hours from symptom onset
measure: Proportion of ischemic stroke patients treated with IVT within 60 minutes of symptom onset
timeFrame: within 60 minutes of symptom onset
measure: Symptomatic intracranial hemorrhage
timeFrame: Within 36 hours from randomization
Other outcomes:
Locations:
city: Garches
country: France
facility: AP-HP - hôpital Raymond Poincaré
city: Le Kremlin-Bicêtre
country: France
facility: AP-HP - hôpital Bicêtre
city: Paris
country: France
facility: AP-HP - hôpital Lariboisière
city: Paris
country: France
facility: AP-HP - hôpital de la Pitié-Salpêtrière
city: Paris
country: France
facility: GHU Paris psychiatrie & neurosciences
city: Paris
country: France
facility: SAMU 75 de Paris
city: Paris
country: France
facility: BSPP, Brigade des Sapeurs-Pompiers de Paris
city: Paris
country: France
facility: AP-HP - hôpital Bichat - Claude-Bernard
city: Paris
country: France
facility: Fondation Ophtalmologique Rothschild
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: GHU Paris Psychiatrie et Neurosciences
name: Guillaume TURC, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: APHP - Centre Hospitalier Universitaire Necker
name: Benoît VIVIEN, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Turc G, Hadziahmetovic M, Walter S, Churilov L, Larsen K, Grotta JC, Yamal JM, Bowry R, Katsanos AH, Zhao H, Donnan G, Davis SM, Hussain MS, Uchino K, Helwig SA, Johns H, Weber JE, Nolte CH, Kunz A, Steiner T, Sacco S, Ebinger M, Tsivgoulis G, Fassbender K, Audebert HJ. Comparison of Mobile Stroke Unit With Usual Care for Acute Ischemic Stroke Management: A Systematic Review and Meta-analysis. JAMA Neurol. 2022 Mar 1;79(3):281-290. doi: 10.1001/jamaneurol.2021.5321.