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

• Sponsor: Centre Hospitalier St Anne (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05649670
• Collaborator: Assistance Publique - Hôpitaux de Paris (Other), Ministry of Health, France (Other)
• Enrollment: 450
• Locations: 10
• Arms: 2
• Anticipated Duration (Months): 44
• Patients Per Site: 45
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute	Other: Mobile Stroke Unit deployment	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 450 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial, PROBE designRandomized controlled trial, PROBE design
• Masking: Single (Outcomes Assessor)
• Masking Description: Blinded assessment of 3-month mRS (via telephone interview)
• Primary Purpose: Treatment
• Official Title: Prehospital Initiation of Reperfusion Therapy for Acute Ischemic Stroke: Randomized Medico-economic Evaluation of a Mobile Stroke Unit.
• Anticipated Study Start Date: Jan 2, 2023
• Anticipated Primary Completion Date: Jan 2, 2026
• Anticipated Study Completion Date: Sep 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention (MSU) Deployment of MSU + conventional ambulance	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).; Other Names: Mobile Stroke Unit management
No Intervention: Control (usual care) Deployment of conventional ambulance

Outcome Measures

Primary Outcome Measures

1. 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

2. 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 Outcome Measures

1. 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

2. 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

3. Time from symptom onset to intravenous thrombolysis (IVT) [up to 4.5 hours from symptom onset]

   Time from symptom onset to IVT bolus

4. Time from symptom onset to mechanical thrombectomy (MT) [up to 24 hours from symptom onset]

   Time from symptom onset to arterial puncture

5. Time from alarm to IVT [up to 4.5 hours from symptom onset]

   Time from ambulance dispatch to IVT bolus

6. Time from alarm to MT [up to 24 hours from symptom onset]

   Time from ambulance dispatch to arterial puncture

7. Death within 3 months after randomization [Within 90 days after randomization]

   All-cause mortality

8. Death within 7 days after randomization [Within 7 days after randomization]

   All-cause mortality

9. 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

10. 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

11. Proportion of ischemic stroke patients treated with IVT within 60 minutes of symptom onset [within 60 minutes of symptom onset]

    Golden hour thrombolysis

12. Symptomatic intracranial hemorrhage [Within 36 hours from randomization]

    ECASS-2 definition

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Kremlin-Bicêtre	Le Kremlin-Bicêtre		France	94275
2	Lariboisière	Paris		France	75010
3	Pitié-Salpêtrière	Paris		France	75013
4	GHU Paris psychiatrie & neurosciences	Paris		France	75014
5	SAMU 75 de Paris	Paris		France	75015
6	BSPP, Brigade des Sapeurs-Pompiers de Paris	Paris		France	75017
7	Hôpital Bichat	Paris		France	75018
8	Fondation Ophtalmologique Rothschild	Paris		France	75019
9	Hôpital Saint Joseph	Paris		France	75674
10	Hôpital Foch	Suresnes		France	92151

Sponsors and Collaborators

• Centre Hospitalier St Anne
• Assistance Publique - Hôpitaux de Paris
• Ministry of Health, France

Investigators

• Principal Investigator: Guillaume TURC, MD, PhD, GHU Paris Psychiatrie et Neurosciences
• Study Director: Benoît VIVIEN, MD, PhD, APHP - Centre Hospitalier Universitaire Necker

Study Documents (Full-Text)

None provided.

More Information

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

• Responsible Party: Centre Hospitalier St Anne
• ClinicalTrials.gov Identifier: NCT05649670
• Other Study ID Numbers: 2018-A02567-48; PRME 15-0677
• First Posted: Dec 14, 2022
• Last Update Posted: Dec 14, 2022
• Last Verified: Dec 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier St Anne: Mobile Stroke Unit; MSU; Intravenous thrombolysis; Emergency Medical Service; Mechanical thrombectomy; Cost-utility; Cost-effectiveness
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of Dec 14, 2022