RecruitingNot ApplicableNCT04701684

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


Sponsor

Philips Clinical & Medical Affairs Global

Enrollment

594 participants

Start Date

Jun 23, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria20

  • 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 is Philips employee or their family members residing with this Philips employee.

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Interventions

DEVICEDirect to Angio Suite (DTAS) Philips' CBCT triage

Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite

PROCEDUREConventional CT/MR triage

First a CT or MRI exam is acquired for triage. In case of an ischemic stroke the patient is then treated in an interventional suite.


Locations(23)

Baptist Medical Center

Jacksonville, Florida, United States

Grady Memorial Hospital/Emory University

Atlanta, Georgia, United States

Montefiore Medical Center

The Bronx, New York, United States

La Sagrada Familia Clinic

José Hernández, Argentina

UZ Brussels

Brussels, Belgium

Hospital Geral de Fortaleza

Fortaleza, Brazil

Hospital de Base

São José do Rio Preto, Brazil

Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba

Vitória, Brazil

Hospices Civils de Lyon

Lyon, France

CHU Montpellier

Montpellier, France

Bicêtre Hospital

Paris, France

University Hospital Bonn (UKB Universitätsklinikum Bonn)

Bonn, Germany

Klinikum Kassel

Kassel, Germany

Universitätsklinikum Schleswig-Holstein Lübeck

Lübeck, Germany

Klinikum rechts der Isar der TU München

Munich, Germany

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Haaglanden Medical Center

The Hague, Netherlands

University Emergency Hospital Bucharest

Bucharest, Romania

Hospital Clinico San Carlos

Madrid, Moncloa - Aravaca, Spain

Vall d'Hebron University Hospital

Barcelona, Spain

Hospital Universitari Doctor Josep Trueta de Girona

Girona, Spain

Hospital Virgen del Rocio

Seville, Spain

İstanbul Aydin University medical park florya hospital

Istanbul, Turkey (Türkiye)

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NCT04701684


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