Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05649670

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

Led by Centre Hospitalier St Anne · Updated on 2024-02-01

450

Participants Needed

11

Research Sites

191 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier St Anne

Lead Sponsor

A

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Emergency call to SAMU or BSPP dispatch centers between 08:00 and 18:00, Monday to Friday
  • Suspected acute stroke according to a dispatcher stroke identification algorithm adapted from the ROSIER scale
  • Symptom onset-to-randomization time 6 hours or less
  • Patient located within the predefined catchment area of the Mobile Stroke Unit
  • Mobile Stroke Unit available at the time of the emergency medical service call
  • Informed consent obtained after randomization at MSU arrival (intervention) or hospital arrival (control)
Not Eligible

You will not qualify if you...

  • Patient confined to more than 50% of waking hours
  • Unknown or uncertain stroke onset time, such as wake-up stroke
  • Medical history of epilepsy
  • Recent epileptic seizure within 12 hours
  • Suspicion of pregnancy
  • Parturient or breastfeeding woman
  • Participation in another interventional study that could affect 3-month outcomes
  • Patient under guardianship or curatorship
  • Patient not affiliated with French Social Security

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

AP-HP - hôpital Raymond Poincaré

Garches, France, 92380

Actively Recruiting

2

AP-HP - hôpital Bicêtre

Le Kremlin-Bicêtre, France, 94275

Actively Recruiting

3

AP-HP - hôpital Lariboisière

Paris, France, 75010

Actively Recruiting

4

AP-HP - hôpital de la Pitié-Salpêtrière

Paris, France, 75013

Actively Recruiting

5

GHU Paris psychiatrie & neurosciences

Paris, France, 75014

Actively Recruiting

6

SAMU 75 de Paris

Paris, France, 75015

Actively Recruiting

7

BSPP, Brigade des Sapeurs-Pompiers de Paris

Paris, France, 75017

Actively Recruiting

8

AP-HP - hôpital Bichat - Claude-Bernard

Paris, France, 75018

Actively Recruiting

9

Fondation Ophtalmologique Rothschild

Paris, France, 75019

Actively Recruiting

10

Hôpital Saint Joseph

Paris, France, 75674

Not Yet Recruiting

11

Hôpital Foch

Suresnes, France, 92151

Actively Recruiting

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Research Team

K

Khaoussou SYLLA, MD, PhD

CONTACT

M

Malha BERRAH, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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