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

Обзор

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.

Подробное описание

Outcomes for stroke patients are closely tied to how fast they receive treatment. Currently, when a possible stroke patient arrives at the emergency department, typically first a CT or MRI exam is acquired for stroke triage. In case of an ischemic stroke the patient is then treated in an interventional suite.

In the DTAS workflow stroke patients are diagnosed and treated in the interventional suite without interruption. The Cone-Beam CT (CBCT) capabilities of the interventional X-ray system are utilized to perform triage, directly followed by stroke treatment.

The primary objective of the WE-TRUST study is to demonstrate that the DTAS triage workflow involving CBCT results in superior patient outcome in ischemic stroke patients with confirmed Large Vessel Occlusion as compared to the conventional CT/MR triage workflow.

The WE-TRUST study will be running in 16+ sites to enroll 500+ patients globally.

Вмешательства

• Устройство Direct to Angio Suite (DTAS) Philips' CBCT triage
  Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite
• Процедура Conventional 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.

Первичные конечные точки

• Distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up [Срок оценки: 90 ± 14 days follow-up]

Вторичные конечные точки (3)

• Median time measurements (door-to-arterial puncture time) [Срок оценки: Peri-procedural time]
• Median time measurements (door-to-reperfusion time) [Срок оценки: Peri-procedural time]
• Distribution of ordinal modified Rankin Scale (mRS) scores [Срок оценки: 90 ± 14 days follow-up]

Критерии участия

Критерии включения

• 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)

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Германия · 4 центра

• University Hospital Bonn (UKB Universitätsklinikum Bonn) — Bonn
• Klinikum Kassel — Kassel
• Universitätsklinikum Schleswig-Holstein Lübeck — Lübeck
• Klinikum rechts der Isar der TU München — Munich

Испания · 4 центра

• Hospital Clinico San Carlos — Madrid
• Vall d'Hebron University Hospital — Barcelona
• Hospital Universitari Doctor Josep Trueta de Girona — Girona
• Hospital Virgen del Rocio — Seville

США · 3 центра

• Baptist Medical Center — Jacksonville
• Grady Memorial Hospital/Emory University — Atlanta
• Montefiore Medical Center — The Bronx

Бразилия · 3 центра

• Hospital Geral de Fortaleza — Fortaleza
• Hospital de Base — São José do Rio Preto
• Hospital Estadual Central - Fundação Estadual de Inovação em Saúde - Inova Capixaba — Vitória

Франция · 3 центра

• Hospices Civils de Lyon — Lyon
• CHU Montpellier — Montpellier
• Bicêtre Hospital — Paris

Нидерланды · 2 центра

• St. Antonius Ziekenhuis — Nieuwegein
• Haaglanden Medical Center — The Hague

Аргентина · 1 центр

• La Sagrada Familia Clinic — José Hernández

Бельгия · 1 центр

• UZ Brussels — Brussels

Румыния · 1 центр

• University Emergency Hospital Bucharest — Bucharest

Turkey (Türkiye) · 1 центр

• İstanbul Aydin University medical park florya hospital — Istanbul

Идентификаторы

NCT: NCT04701684 · XCY607-130512

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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