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RecruitingNAINTERVENTIONAL

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

The ASPHALT study is investigating if Mobile Stroke Units (MSUs) can improve recovery for people having a stroke. MSUs are ambulances fitted with brain scanners that allow doctors to start life-saving treatments, like clot-busting medication, much sooner than if a patient had to wait to get to a hospital. This study in France will compare results from patients treated by MSUs with those who receive standard hospital care. Researchers will follow 450 people with acute stroke for three months to see if earlier treatment leads to better recovery and is a cost-effective approach for the healthcare system. The aim is to find out if bringing hospital-level stroke care to the patient faster makes a real difference.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Centre Hospitalier St Anne
Enrolment target
450
Start
16 Oct 2023
Estimated completion
16 Jun 2027

What is this study about?

When someone has a stroke, getting treatment quickly is incredibly important. The faster a blocked blood vessel in the brain can be opened, the better the chances of recovery. Usually, people have to wait until they arrive at a hospital to have scans and start treatment.

This study, called ASPHALT, is looking at a new way to speed things up. It involves using special ambulances called Mobile Stroke Units (MSUs). These units are like mini-hospitals on wheels, equipped with a CT scanner that can take pictures of the brain right away. This means doctors can diagnose the stroke and start treatments, such as clot-busting medication, much sooner – even before the person gets to the full hospital.

The main goal of ASPHALT is to see if using these Mobile Stroke Units truly helps people recover better from a stroke compared to the usual care. They also want to understand if this faster treatment method is worth the cost for the healthcare system. The study hopes to gather clear evidence to help decide if MSUs should be used more widely.

Key takeaways

  • This study compares Mobile Stroke Units (MSUs) to standard hospital stroke care.
  • MSUs bring brain scanning and early treatment to the patient.
  • It aims to see if early treatment improves recovery and is a good use of healthcare funds.
  • 450 stroke patients in France will be followed for 3 months.
  • Participation involves being randomly assigned to MSU care or standard hospital care.

Who may be eligible?

This study is particularly looking for adults in France who are experiencing a suspected acute stroke. You would typically be considered if you called emergency services (like SAMU or BSPP in Paris) between 8 AM and 6 PM on a weekday, and your symptoms started within the last six hours. You would also need to be in an area where the Mobile Stroke Unit can reach you and be available at the time of your emergency call.

However, some things might mean you can't join the study. For example, if you spend most of your waking hours needing help, or if the exact time your stroke symptoms started is unknown (like if you woke up with symptoms). People with a history of epilepsy, recent seizures, or who are pregnant or breastfeeding are also usually not included. If you're involved in another study that could affect your recovery at three months, or if you're under legal guardianship, you wouldn't be able to participate. You also need to be part of the French Social Security system.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you an adult experiencing suspected stroke symptoms?
  2. Did your symptoms start within the last 6 hours?
  3. Did you call emergency services during weekday daytime hours?
  4. Are you able to provide consent for treatment, or can a family member provide it for you later?
  5. Do you not have a history of epilepsy or recent seizures (within 12 hours)?
Answer every question to see your result.

What does participation involve?

If you are considered for this study, you might be randomly chosen to either receive care from a Mobile Stroke Unit at your location or to receive standard care, meaning you'd be taken directly to the hospital for treatment. The decision about which type of care you receive is made randomly, like flipping a coin. You will be asked for your consent to take part either when the Mobile Stroke Unit arrives (if you're in that group) or when you reach the hospital (if you're in the standard care group).

Researchers will then closely follow your recovery for a period of three months. During this time, they will collect information about your health and how well you are recovering. There are no extra hospital visits or treatments specifically for the study itself beyond your usual medical care, but your progress and costs related to your care will be carefully tracked.

Potential risks and benefits

Taking part in this study means you'll either receive very quick stroke care from a Mobile Stroke Unit or the usual high-quality care at a hospital. The main potential benefit is that receiving faster treatment from a Mobile Stroke Unit *might* lead to a better recovery from your stroke. However, it's also possible that there might be no difference compared to standard care, or that very early treatment has its own minor risks, which would be explained fully by the medical team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (11)

  • AP-HP - hôpital Raymond Poincaré
    Verified postcode
    Garches, France· Recruiting
  • AP-HP - hôpital Bicêtre
    Verified postcode
    Le Kremlin-Bicêtre, France· Recruiting
  • AP-HP - hôpital Lariboisière
    Verified postcode
    Paris, France· Recruiting
  • AP-HP - hôpital de la Pitié-Salpêtrière
    Verified postcode
    Paris, France· Recruiting
  • GHU Paris psychiatrie & neurosciences
    Verified postcode
    Paris, France· Recruiting
  • SAMU 75 de Paris
    Verified postcode
    Paris, France· Recruiting
  • BSPP, Brigade des Sapeurs-Pompiers de Paris
    Verified postcode
    Paris, France· Recruiting
  • AP-HP - hôpital Bichat - Claude-Bernard
    Verified postcode
    Paris, France· Recruiting
  • Fondation Ophtalmologique Rothschild
    Verified postcode
    Paris, France· Recruiting
  • Hôpital Saint Joseph
    Verified postcode
    Paris, France· Not yet recruiting
  • Hôpital Foch
    Verified postcode
    Suresnes, France· Recruiting

Common questions

What is a Mobile Stroke Unit (MSU)?

It's a special ambulance with a brain scanner (CT scanner) and stroke experts on board, allowing doctors to diagnose and start treating a stroke right where the patient is.

What kind of stroke is this study about?

It's about 'acute ischemic stroke,' which is caused by a blood clot blocking blood flow to part of the brain. This is the most common type of stroke.

Will I definitely get treated by a Mobile Stroke Unit if I join?

No, it's a 'randomised' study. This means you'll be randomly assigned to either receive care from an MSU or standard care at a hospital. It's like a fair coin toss.

How long will I be involved in the study?

Researchers will follow your recovery for three months after your stroke to see how you are doing.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time without it affecting your medical care.

How to find out more

Khaoussou SYLLA, MD, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Acute Stroke: Prehospital Versus In-HospitAL Initiation of R…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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