Resumen

El estudio WE-TRUST es un ensayo clínico aleatorizado multicéntrico para evaluar el impacto del flujo de trabajo de Acceso Directo a la Sala de Angiografía (DTAS, por sus siglas en inglés) en los resultados de los pacientes con accidente cerebrovascular.

Descripción detallada

Los resultados de los pacientes con accidente cerebrovascular están estrechamente relacionados con la rapidez con que reciben el tratamiento. Actualmente, cuando un paciente con posible accidente cerebrovascular llega al servicio de urgencias, generalmente se realiza primero una tomografía computarizada (TC) o una resonancia magnética (RM) para el triaje del accidente cerebrovascular. En caso de accidente cerebrovascular isquémico, el paciente es luego tratado en una sala de intervencionismo. En el flujo de trabajo DTAS, los pacientes con accidente cerebrovascular son diagnosticados y tratados en la sala de intervencionismo sin interrupciones. Las capacidades de TC de haz cónico (CBCT) del sistema de rayos X intervencionista se utilizan para realizar el triaje, seguido directamente por el tratamiento del accidente cerebrovascular. El objetivo principal del estudio WE-TRUST es demostrar que el flujo de trabajo de triaje DTAS que emplea CBCT resulta en un mejor resultado clínico en pacientes con accidente cerebrovascular isquémico con oclusión de gran vaso confirmada, en comparación con el flujo de trabajo de triaje convencional por TC/RM. El estudio WE-TRUST se llevará a cabo en 16 o más centros para inscribir a más de 500 pacientes a nivel mundial.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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)

Criterios de exclusión

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.
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

Intervenciones

device

Direct to Angio Suite (DTAS) Philips' CBCT triage

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

procedure

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.

WE-TRUST (Optimización del flujo de trabajo para reducir el tiempo hasta la reperfusión endovascular en el tratamiento ultrarrápido del accidente cerebrovascular)

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Direct to Angio Suite (DTAS) Philips' CBCT triage

Conventional CT/MR triage

Ubicaciones

La Sagrada Familia Clinic

Patrocinadores

Contactos

Gerrits

Eshuis