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NCT04701684From ClinicalTrials.govRecruiting

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

  • Stroke, Acute

At a glance

Phase
Phase not stated
Study type
Interventional
Sponsor
Philips Clinical & Medical Affairs Global
Enrolment target
594
Started
23 June 2021
Main results due
1 April 2027
Study sites
24
Registry updated
29 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(24)

  • 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

    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

  • İstinye Üniversitesi Gaziosmanpaşa Hastanesi

    Istanbul, Turkey (Türkiye)

    Not yet recruiting

Showing 24 of 24 sites. 17 of the 24 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04701684. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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