Stroke, Acute
Conditions
Keywords
Mobile Stroke Unit, MSU, Intravenous thrombolysis, Emergency Medical Service, Mechanical thrombectomy, Cost-utility, Cost-effectiveness
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.
Interventions
OTHERMobile Stroke Unit deployment
Deployment of an MSU + conventional ambulance, allowing prehospital CT-scan imaging with intracranial CT angiography. This will allow prehospital intravenous thrombolysis and optimal triage (i.e. accurate identification of patients with large vessel occlusion, who are eligible for mechanical thrombectomy).
Sponsors
Assistance Publique - Hôpitaux de Paris
Ministry of Health, France
Centre Hospitalier St Anne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded assessment of 3-month mRS (via telephone interview)
Intervention model description
Randomized controlled trial, PROBE design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 symptom onset to mechanical thrombectomy (MT) | up to 24 hours from symptom onset | Time from symptom onset to arterial puncture |
| Time from alarm to IVT | up to 4.5 hours from symptom onset | Time from ambulance dispatch to IVT bolus |
| Time from alarm to MT | up to 24 hours from symptom onset | Time from ambulance dispatch to arterial puncture |
| Death within 3 months after randomization | Within 90 days after randomization | All-cause mortality |
| 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 |
| 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 |
| 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 |
| 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 |
| Death within 7 days after randomization | Within 7 days after randomization | All-cause mortality |
| 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 |
Countries
France
Contacts
Primary ContactKhaoussou SYLLA, MD, PhD
Backup ContactMalha BERRAH, MSc
Outcome results
None listed