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

Официальное название

Prehospital Initiation of Reperfusion Therapy for Acute Ischemic Stroke: Randomized Medico-economic Evaluation of a Mobile Stroke Unit.

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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).

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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))

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 11 центров

• 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
• … и ещё 3 центра

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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