Optimizing Stroke Treatment Workflow for Faster Recovery

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

This study is testing a new way to quickly treat stroke patients using advanced technology to see if it helps them recover faster and better than the usual methods.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 594 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Philips Clinical & Medical Affairs Global (Industry-sponsored)
• Locations: 23 sites (Jacksonville, Florida and 22 other locations)
• Trial ID: NCT04701684 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with suspected acute ischemic stroke and a baseline NIHSS score of 10 or higher.

Not a fit: Patients with significant pre-stroke functional disability or those with contraindications for endovascular treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to faster treatment times and improved recovery outcomes for stroke patients.

How similar studies have performed: Previous studies have shown that optimizing treatment workflows can improve outcomes in stroke care, suggesting that this approach may be effective.

Eligibility criteria

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 this trial is running

Jacksonville, Florida and 22 other locations

• Baptist Medical Center — Jacksonville, Florida, United States (Recruiting)
• Grady Memorial Hospital/Emory University — Atlanta, Georgia, United States (Not_yet_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 de Base — São José do Rio Preto, Brazil (Not_yet_recruiting)
• Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba — Vitória, Brazil (Recruiting)
• Hospices Civils de Lyon — Lyon, France (Completed)
• CHU Montpellier — Montpellier, France (Recruiting)
• Bicêtre Hospital — Paris, France (Recruiting)
• University Hospital Bonn (UKB Universitätsklinikum Bonn) — Bonn, Germany (Recruiting)
• Klinikum Kassel — Kassel, Germany (Recruiting)
• Universitätsklinikum Schleswig-Holstein Lübeck — Lübeck, Germany (Recruiting)
• Klinikum rechts der Isar der TU München — Munich, Germany (Recruiting)
• St. Antonius Ziekenhuis — Nieuwegein, Netherlands (Completed)
• Haaglanden Medical Center — The Hague, Netherlands (Withdrawn)
• University Emergency Hospital Bucharest — Bucharest, Romania (Not_yet_recruiting)
• Hospital Clinico San Carlos — Madrid, Moncloa - Aravaca, Spain (Recruiting)
• Vall d'Hebron University Hospital — Barcelona, Spain (Recruiting)
• Hospital Universitari Doctor Josep Trueta de Girona — Girona, Spain (Recruiting)
• Hospital Virgen del Rocio — Seville, Spain (Recruiting)
• İstanbul Aydin University medical park florya hospital — Istanbul, Turkey (Türkiye) (Completed)

Study contacts

• Principal investigator: Raul G Nogueira — UPMC Stroke Institute, Pittsburgh
• Study coordinator: Gerrits

Conditions Stroke, Acute