About this trial
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
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Direct to Angio Suite (DTAS) Philips' CBCT triage
- Conventional CT/MR triage