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

Ki vehet részt

• 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)

Ki nem vehet részt

• 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 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)
• Subject participates in a potentially confounding drug or device trial during the course of the study
• 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)
• 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
• 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.)
• 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
• 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)
• Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman)
• Clinical exclusion criteria:
• Patients with extreme vomiting
• Patients that are extremely agitated
• Cerebral vasculitis
• 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
• 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