RecruitingNAINTERVENTIONAL

WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)

The WE-TRUST study is testing a faster way to treat people who have just had a stroke. When someone might be having a stroke, they usually have brain scans like CT or MRI first. If it's a specific type of stroke, they then go to a special X-ray room for treatment. This study is looking at whether it's better to go straight to that X-ray room (the 'Direct to Angio Suite' or DTAS approach) where a special kind of scan can be done there, immediately followed by treatment. The main aim is to find out if this quicker method helps people recover better from their stroke compared to the usual process. Over 500 patients from various hospitals around the world will be involved in this study.

At a glance

Status

Recruiting

Phase

Sponsor

Philips Clinical & Medical Affairs Global

Enrolment target

594

Start

23 Jun 2021

Estimated completion

01 Apr 2027

Stroke, Acute

What is this study about?

When someone has a stroke, getting treatment quickly is really important for saving brain cells and improving their chances of a good recovery. Currently, if you arrive at the hospital with stroke symptoms, doctors usually start by doing scans like a CT or MRI to confirm it's a stroke and figure out what kind.

After these initial scans, if it's a specific type of stroke where a blood clot is blocking a large blood vessel in the brain (called an ischemic stroke with a large vessel occlusion), you would then be moved to a special X-ray room for a treatment called endovascular reperfusion. This treatment uses thin tubes to remove the clot.

The WE-TRUST study is exploring a new idea. Instead of having separate scans first, this new approach means you would go straight into the special X-ray room. In this room, they have a type of scan called Cone-Beam CT (CBCT) built into the X-ray machine. This scan can quickly check for a stroke, and if confirmed, doctors can start the clot-removing treatment right away, without needing to move you again. The study wants to see if this faster, uninterrupted process leads to better recovery for patients.

Key takeaways

The study tests a faster way to treat certain strokes.
It compares new 'direct' treatment path with usual hospital process.
Faster treatment could lead to better stroke recovery.
It uses a special scanner in the treatment room itself.
Over 500 patients globally will take part.

Who may be eligible?

To be part of this study, you'd generally need to be an adult, aged 18 or older. You should also have symptoms of a severe stroke (your doctor will check this using a specific score) and have been able to look after yourself well before the stroke, meaning you didn't have significant existing disability.

Crucially, you would need to get to the hospital very quickly after your stroke symptoms started – within six hours, or within 12 hours if it was a 'wake-up stroke' (where you woke up with symptoms and aren't sure exactly when it started), and you arrived at the hospital within six hours of waking up.

There are also some reasons why you wouldn't be able to join. These include certain blood conditions, very low blood sugar, or if your blood pressure is very high and can't be controlled. If you've already had the necessary scans at another hospital and don't need them repeated, you also wouldn't be eligible for this specific study. Your doctors will carefully check all these points to see if you're a good fit.

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.

Are you 18 or older?
Did you have a stroke recently (within 6-12 hours of symptom onset)?
Were you able to live independently before your stroke?
Are your stroke symptoms severe enough for this type of treatment?
Do you have any major blood clotting problems or very low blood sugar?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, the main change would be how quickly you get your initial scans and treatment. Instead of having separate scans in a different room first, you would go directly to a special X-ray examination room. In this room, doctors would use a built-in scanner to diagnose your stroke. If it's the type of stroke the study is looking at, treatment to remove the clot would begin immediately in the same room.

Beyond this, you would receive the standard care for stroke recovery, and doctors would closely monitor your progress. The study aims to follow how well you recover from your stroke, but it doesn't involve any extra medications or lengthy visits beyond what's usually needed for stroke care. The total duration of your involvement in the study would mostly depend on how long your doctors typically follow up after a stroke.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of faster treatment for your stroke, which might lead to a better recovery. However, it's important to remember that this is a research study, and there's no guarantee of specific benefits. The main risk is that moving directly to the treatment room might delay some initial assessments, or the specialized scan might not be as clear in all situations as traditional scans, though the study aims to show it is effective. You will be closely monitored, and your medical team will ensure your safety is a top priority. Remember, you can choose to stop participating in the study at any time without affecting your medical care.

Locations (23)

Baptist Medical Center
Verified postcode
Jacksonville, United States· Recruiting
Grady Memorial Hospital/Emory University
Verified postcode
Atlanta, United States· Not yet recruiting
Montefiore Medical Center
Verified postcode
The Bronx, United States· Recruiting
La Sagrada Familia Clinic
Verified postcode
José Hernández, Argentina· Recruiting
UZ Brussels
Verified postcode
Brussels, Belgium· Recruiting
Hospital Geral de Fortaleza
Verified postcode
Fortaleza, Brazil· Recruiting
Hospital de Base
Verified postcode
São José do Rio Preto, Brazil· Not yet recruiting
Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba
Verified postcode
Vitória, Brazil· Recruiting
Hospices Civils de Lyon
Verified postcode
Lyon, France· Completed
CHU Montpellier
Verified postcode
Montpellier, France· Recruiting
Bicêtre Hospital
Verified postcode
Paris, France· Recruiting
University Hospital Bonn (UKB Universitätsklinikum Bonn)
Verified postcode
Bonn, Germany· Recruiting

Common questions

What is the purpose of the WE-TRUST study?

The study aims to see if starting stroke treatment immediately in a special X-ray room, rather than doing initial scans first, leads to better outcomes for stroke patients.

What is an ischemic stroke?

An ischemic stroke happens when a blood clot blocks blood flow to part of the brain, causing brain cells to die.

What does 'Direct to Angio Suite' (DTAS) mean?

It means you go straight to the special X-ray room where doctors can both diagnose your stroke with a built-in scanner and start treatment right away, without moving to different rooms.

Will I still get the best care if I don't join the study?

Absolutely. Whether you join the study or not, you will always receive high-quality medical care for your stroke according to standard hospital practices.

Is this a new medicine trial?

No, this is not a trial for new medicine. It's looking at a different way of organising the steps involved in diagnosing and treating certain types of stroke.

How to find out more

Gerrits

carin.gerrits@philips.com +31 6 55 48 29 31 Official trial record

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