NCT04701684 WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)

Eligibility & Interventions

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This trial targets 594 participants in total. It began in 2021-06-23 with a primary completion date of 2027-04-01.

Brief 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 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.

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