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.

Overview

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

• Other Mobile 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).

Primary outcome measures

• Incremental Cost-Utility Ratio (ICUR) [Time frame: 3 months]
• Key secondary outcome: Modified Rankin Scale (mRS) at 3 months [Time frame: 90 +/- 14 days]

Secondary outcome measures (12)

• ICUR at 3 months [Time frame: 90 +/- 14 days]
• ICUR at 5 years [Time frame: 5 years]
• Time from symptom onset to intravenous thrombolysis (IVT) [Time frame: up to 4.5 hours from symptom onset]
• Time from symptom onset to mechanical thrombectomy (MT) [Time frame: up to 24 hours from symptom onset]
• Time from alarm to IVT [Time frame: up to 4.5 hours from symptom onset]
• Time from alarm to MT [Time frame: up to 24 hours from symptom onset]
• Death within 3 months after randomization [Time frame: Within 90 days after randomization]
• Death within 7 days after randomization [Time frame: Within 7 days after randomization]
• Proportion of ischemic stroke patients treated with IVT [Time frame: up to 4.5 hours from symptom onset]
• Proportion of ischemic stroke patients with MT [Time frame: up to 24 hours from symptom onset]
• Proportion of ischemic stroke patients treated with IVT within 60 minutes of symptom onset [Time frame: within 60 minutes of symptom onset]
• Symptomatic intracranial hemorrhage [Time frame: Within 36 hours from randomization]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

France · 11 centers

• AP-HP - hôpital Raymond Poincaré — Garches
• AP-HP - hôpital Bicêtre — Le Kremlin-Bicêtre
• AP-HP - hôpital Lariboisière — Paris
• AP-HP - hôpital de la Pitié-Salpêtrière — Paris
• GHU Paris psychiatrie & neurosciences — Paris
• SAMU 75 de Paris — Paris
• BSPP, Brigade des Sapeurs-Pompiers de Paris — Paris
• AP-HP - hôpital Bichat - Claude-Bernard — Paris
• … and 3 more centers

Publications

• 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. JAM PMID 35129584

Identifiers

NCT: NCT05649670 · 2018-A02567-48 · PRME 15-0677

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗