Acute Stroke: Prehospital Versus In-HospitAL Initiation of Recanalization Therapy- ASPHALT

Not Applicable

Recruiting

• Conditions: Stroke, Acute
• Interventions: Other: Mobile Stroke Unit deployment

• Registration Number: NCT05649670
• Lead Sponsor: Centre Hospitalier St Anne

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.

Study Timeline

• Study First Submitted: 2022-12-02
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-14
• Status Verified: 2023-10
• Study Start: 2023-10-16
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2026-10-16
• Study Completion: 2027-06-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention (MSU)	Mobile Stroke Unit deployment	Deployment of MSU + conventional ambulance

Primary Outcome Measures

Name	Time	Method
Key secondary outcome: Modified Rankin Scale (mRS) at 3 months	90 +/- 14 days	Modified Rankin scale, assessed in a blinded fashion (range, 0 to 6, with 0 indicating no disability, 3 indicating moderate disability, and 6 indicating death)
Incremental Cost-Utility Ratio (ICUR)	3 months	ICUR in the lifetime horizon, based on extrapolated results of the Modified Rankin Scale (mRS) at 3 months and incremental costs prospectively collected during the first 3 months

Secondary Outcome Measures

Name	Time	Method
Proportion of ischemic stroke patients with MT	up to 24 hours from symptom onset	Proportion of patient treated with MT among those with confirmed ischemic stroke
Time from symptom onset to mechanical thrombectomy (MT)	up to 24 hours from symptom onset	Time from symptom onset to arterial puncture
ICUR at 5 years	5 years	Incremental Cost-Utility Ratio based on extrapolated results of the Modified Rankin Scale (mRS) at 3 months and incremental costs prospectively collected during the first 3 months
Proportion of ischemic stroke patients treated with IVT	up to 4.5 hours from symptom onset	Proportion of patient treated with IVT among those with confirmed ischemic stroke
Time from alarm to MT	up to 24 hours from symptom onset	Time from ambulance dispatch to arterial puncture
ICUR at 3 months	90 +/- 14 days	Incremental Cost-Utility Ratio based on results of the Modified Rankin Scale (mRS) at 3 months and incremental costs prospectively collected during the first 3 months
Time from symptom onset to intravenous thrombolysis (IVT)	up to 4.5 hours from symptom onset	Time from symptom onset to IVT bolus
Time from alarm to IVT	up to 4.5 hours from symptom onset	Time from ambulance dispatch to IVT bolus
Death within 3 months after randomization	Within 90 days after randomization	All-cause mortality
Death within 7 days after randomization	Within 7 days after randomization	All-cause mortality
Proportion of ischemic stroke patients treated with IVT within 60 minutes of symptom onset	within 60 minutes of symptom onset	Golden hour thrombolysis
Symptomatic intracranial hemorrhage	Within 36 hours from randomization	ECASS-2 definition

Trial Locations

Locations (11)

AP-HP - hôpital de la Pitié-Salpêtrière; 🇫🇷 Paris, France

GHU Paris psychiatrie & neurosciences; 🇫🇷 Paris, France

AP-HP - hôpital Raymond Poincaré; 🇫🇷 Garches, France

AP-HP - hôpital Lariboisière; 🇫🇷 Paris, France

AP-HP - hôpital Bicêtre; 🇫🇷 Le Kremlin-Bicêtre, France

SAMU 75 de Paris; 🇫🇷 Paris, France

Hôpital Saint Joseph; 🇫🇷 Paris, France

AP-HP - hôpital Bichat - Claude-Bernard; 🇫🇷 Paris, France

Fondation Ophtalmologique Rothschild; 🇫🇷 Paris, France

BSPP, Brigade des Sapeurs-Pompiers de Paris; 🇫🇷 Paris, France

Hôpital Foch; 🇫🇷 Suresnes, France