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

NCT05649670 | Recruiting

• 2 other identifiers: 2018-A02567-48PRME 15-0677
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 11

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.

Conditions

Stroke, Acute

Keywords

Mobile Stroke Unit; MSU; Intravenous thrombolysis; Emergency Medical Service; Mechanical thrombectomy; Cost-utility; Cost-effectiveness

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (12)

• ICUR at 3 months

  90 +/- 14 days

• ICUR at 5 years

  5 years

• Time from symptom onset to intravenous thrombolysis (IVT)

  up to 4.5 hours from symptom onset

• Time from symptom onset to mechanical thrombectomy (MT)

  up to 24 hours from symptom onset

• Time from alarm to IVT

  up to 4.5 hours from symptom onset

Study Arms (2)

Intervention (MSU)

EXPERIMENTAL

Deployment of MSU + conventional ambulance

Other: Mobile Stroke Unit deployment

Control (usual care)

NO INTERVENTION

Deployment of conventional ambulance

Interventions

Mobile Stroke Unit deployment OTHER

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).

Also known as: Mobile Stroke Unit management

Intervention (MSU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (11)

AP-HP - hôpital Raymond Poincaré

Garches, 92380, France

RECRUITING

AP-HP - hôpital Bicêtre

Le Kremlin-Bicêtre, 94275, France

RECRUITING

AP-HP - hôpital Lariboisière

Paris, 75010, France

RECRUITING

AP-HP - hôpital de la Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

GHU Paris psychiatrie & neurosciences

Paris, 75014, France

RECRUITING

SAMU 75 de Paris

Paris, 75015, France

RECRUITING

BSPP, Brigade des Sapeurs-Pompiers de Paris

Paris, 75017, France

RECRUITING

AP-HP - hôpital Bichat - Claude-Bernard

Paris, 75018, France

RECRUITING

Fondation Ophtalmologique Rothschild

Paris, 75019, France

RECRUITING

Hôpital Saint Joseph

Paris, 75674, France

NOT YET RECRUITING

Hôpital Foch

Suresnes, 92151, France

RECRUITING

Related 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.

  PMID: 35129584 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Guillaume TURC, MD, PhD

  GHU Paris Psychiatrie et Neurosciences

  PRINCIPAL INVESTIGATOR

• Benoît VIVIEN, MD, PhD

  APHP - Centre Hospitalier Universitaire Necker

  STUDY DIRECTOR

Central Study Contacts

Khaoussou SYLLA, MD, PhD

CONTACT

+33 (01) 45 65 76 78; k.sylla@ghu-paris.fr

Malha BERRAH, MSc

CONTACT

+33 (0)1 56 09 58 22; malha.berrah@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded assessment of 3-month mRS (via telephone interview)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial, PROBE design

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 14, 2022
• Study Start: October 16, 2023
• Primary Completion (Estimated): October 16, 2026
• Study Completion (Estimated): June 16, 2027
• Last Updated: February 1, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing to obtain IPD must meet the sponsor and PI team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and time frame. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (11)