Optimizing Stroke Treatment Workflow for Faster Recovery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The WE-TRUST study is a multi-center randomized clinical trial aimed at improving outcomes for stroke patients by implementing a Direct to Angio Suite (DTAS) workflow. This innovative approach allows for immediate diagnosis and treatment of ischemic strokes in the interventional suite, utilizing Cone-Beam CT (CBCT) technology for triage. By comparing this method to the conventional CT/MR triage workflow, the study seeks to demonstrate that DTAS can significantly reduce treatment time and enhance patient outcomes for those with confirmed Large Vessel Occlusion. The trial will enroll over 500 patients across 16 global sites.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subject is 18 years of age or older, or of legal age to give informed consent per state or national law.
* Baseline NIHSS score obtained prior to randomization must be equal or higher than 10 points.
* Subjects with no significant pre-stroke functional disability (modified Rankin scale 0 - 2).
* Subjects suspected of acute ischemic stroke with an estimated arrival time at a stroke center (clinical investigational site participating in this study) \< 6 hours from symptom onset OR wake-up stroke with time last known well of \< 12 hours and symptoms discovered within 6 hours from arrival time at a stroke center. Symptom onset is defined as point in time the patient was last known well (at baseline).
* Informed consent obtained from patient or his or her legally designated representative (if locally required).
* Angiography suite immediately available.
* Endovascular treatment team immediately available (Neurologist, Neurointerventionalist, Anesthesiologist, Nursing, Technicians as per local standard practice)

Exclusion Criteria:

Clinical exclusion criteria:

* Known hemorrhagic diathesis, coagulation factor deficiency, or oral anticoagulant therapy with INR \> 3.0
* Known baseline platelet count \< 30.000/μL
* Baseline blood glucose of \< 50mg/dL (\< 2.78mmol/l)
* For patients receiving thrombolysis: severe, sustained hypertension (SBP \> 185 mm Hg or DBP \> 110 mm Hg). Note: If the blood pressure can be successfully reduced and maintained at the acceptable level using AHA/ASA guidelines recommended medication (including IV antihypertensive drips), the patient can be enrolled.
* Patients from a transfer center (Primary Stroke Center) with a CT/MR that is not required to be redone in the Comprehensive Stroke Center as per discretion of the physician or per local standards (e.g. CT/MR less than 90 minutes old).
* Patients in coma (NIHSS item of consciousness \>1) defined as totally unresponsive; responding only with reflexes or being areflexic (Intubated patients for transfer could be randomized only in case an NIHSS is obtained by a neurologist prior transportation).
* Patients with extreme vomiting
* Patients that are extremely agitated
* Seizures at stroke onset which would preclude obtaining a baseline NIHSS
* Serious, advanced, or terminal illness with anticipated life expectancy of less than one year.
* Patients acquired stroke while in-hospital
* History of life-threatening allergy (more than rash) to contrast medium
* Cerebral vasculitis
* Patients with a pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, mRS score at baseline must be ≤2. This excludes patients who are severely demented, require constant assistance in a nursing home type setting or who live at home but are not fully independent in activities of daily living (toileting, dressing, eating, cooking and preparing meals, etc.)
* Unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitor from overseas).
* Patients with unstable clinical status who require emergent life support care
* Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
* Subject participates in a potentially confounding drug or device trial during the course of the study.
* Woman of childbearing potential who is known to be pregnant on admission.
* Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman)
* Subject is Philips employee or their family members residing with this Philips employee.

Where it's running

• Baptist Medical Center
  Jacksonville, Florida, United States Recruiting
• Montefiore Medical Center
  The Bronx, New York, United States Recruiting
• La Sagrada Familia Clinic
  José Hernández, Argentina Recruiting
• UZ Brussels
  Brussels, Belgium Recruiting
• Hospital Geral de Fortaleza
  Fortaleza, Brazil Recruiting
• Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba
  Vitória, Brazil Recruiting

Study contacts

• Principal investigator: Raul G Nogueira — UPMC Stroke Institute, Pittsburgh
• Study coordinator: Gerrits
• Email: carin.gerrits@philips.com
• Phone: +31 6 55 48 29 31

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Inter-Limb Transfer after Acute Stroke

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• Immersive Virtual Reality in Upper-Limb Rehabilitation After Stroke

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• Anakinra After Endovascular Therapy for Ischemic Stroke

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  Recruiting at 6 sites Phase 2 Beijing Tiantan Hospital · Beijing, Beijing Municipality and 5 other locations · NCT07423975

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.