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

Stroke, Acute Clinical Trial

— ASPHALT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05649670
• Other study ID #: 2018-A02567-48
• Secondary ID: PRME 15-0677
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: June 16, 2027

Study information

• Verified date: October 2023
• Source: Centre Hospitalier St Anne
• Contact: Khaoussou SYLLA, MD, PhD
• Phone: +33 (01) 45 65 76 78
• Email: k.sylla[@]ghu-paris.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: June 16, 2027
• Est. primary completion date: October 16, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

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).

Locations

Country	Name	City	State
France	AP-HP - hôpital Raymond Poincaré	Garches
France	AP-HP - hôpital Bicêtre	Le Kremlin-Bicêtre
France	AP-HP - hôpital Bichat - Claude-Bernard	Paris
France	AP-HP - hôpital de la Pitié-Salpêtrière	Paris
France	AP-HP - hôpital Lariboisière	Paris
France	BSPP, Brigade des Sapeurs-Pompiers de Paris	Paris
France	Fondation Ophtalmologique Rothschild	Paris
France	GHU Paris psychiatrie & neurosciences	Paris
France	Hôpital Saint Joseph	Paris
France	SAMU 75 de Paris	Paris
France	Hôpital Foch	Suresnes

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier St Anne	Assistance Publique - Hôpitaux de Paris, Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. JAMA Neurol. 2022 Mar 1;79(3):281-290. doi: 10.1001/jamaneurol.2021.5321. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental Cost-Utility Ratio (ICUR)	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	3 months
Primary	Key secondary outcome: Modified Rankin Scale (mRS) at 3 months	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)	90 +/- 14 days
Secondary	ICUR at 3 months	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	90 +/- 14 days
Secondary	ICUR at 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	5 years
Secondary	Time from symptom onset to intravenous thrombolysis (IVT)	Time from symptom onset to IVT bolus	up to 4.5 hours from symptom onset
Secondary	Time from symptom onset to mechanical thrombectomy (MT)	Time from symptom onset to arterial puncture	up to 24 hours from symptom onset
Secondary	Time from alarm to IVT	Time from ambulance dispatch to IVT bolus	up to 4.5 hours from symptom onset
Secondary	Time from alarm to MT	Time from ambulance dispatch to arterial puncture	up to 24 hours from symptom onset
Secondary	Death within 3 months after randomization	All-cause mortality	Within 90 days after randomization
Secondary	Death within 7 days after randomization	All-cause mortality	Within 7 days after randomization
Secondary	Proportion of ischemic stroke patients treated with IVT	Proportion of patient treated with IVT among those with confirmed ischemic stroke	up to 4.5 hours from symptom onset
Secondary	Proportion of ischemic stroke patients with MT	Proportion of patient treated with MT among those with confirmed ischemic stroke	up to 24 hours from symptom onset
Secondary	Proportion of ischemic stroke patients treated with IVT within 60 minutes of symptom onset	Golden hour thrombolysis	within 60 minutes of symptom onset
Secondary	Symptomatic intracranial hemorrhage	ECASS-2 definition	Within 36 hours from randomization