Prehospital Initiation of Reperfusion Therapy for Acute Ischemic Stroke: Randomized Medico-economic Evaluation of a Mobile Stroke Unit.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 450
- 试验地点
- 22
- 主要终点
- Key secondary outcome: Modified Rankin Scale (mRS) at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded assessment of 3-month mRS (via telephone interview)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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))
排除标准
- •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
结局指标
主要结局
Key secondary outcome: Modified Rankin Scale (mRS) at 3 months
时间窗: 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)
时间窗: 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
次要结局
- ICUR at 5 years(5 years)
- Proportion of ischemic stroke patients treated with IVT(up to 4.5 hours from symptom onset)
- ICUR at 3 months(90 +/- 14 days)
- Time from symptom onset to intravenous thrombolysis (IVT)(up to 4.5 hours from symptom onset)
- Time from alarm to IVT(up to 4.5 hours from symptom onset)
- Death within 3 months after randomization(Within 90 days after randomization)
- Death within 7 days after randomization(Within 7 days after randomization)
- Proportion of ischemic stroke patients treated with IVT within 60 minutes of symptom onset(within 60 minutes of symptom onset)
- Symptomatic intracranial hemorrhage(Within 36 hours from randomization)
- Time from symptom onset to mechanical thrombectomy (MT)(up to 24 hours from symptom onset)
- Time from alarm to MT(up to 24 hours from symptom onset)
- Proportion of ischemic stroke patients with MT(up to 24 hours from symptom onset)