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

Recruiting now · Not applicable

Conditions studied: Stroke, Acute

In brief

The WE-TRUST study is a multi-center randomized clinical trial to assess the impact of a Direct to Angio Suite (DTAS) workflow on stroke patient outcomes.

Key facts

Study ID

NCT04701684

Run by

Philips Clinical & Medical Affairs Global

People needed

594

Starts

2021-06-23

Expected to finish

2027-04-01

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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