Status:
RECRUITING
WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)
Lead Sponsor:
Philips Clinical & Medical Affairs Global
Conditions:
Stroke, Acute
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Detailed Description
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 acq...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
594 Patients enrolled
Trial Details
Trial ID
NCT04701684
Start Date
June 23 2021
End Date
April 1 2027
Last Update
December 22 2025
Active Locations (22)
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1
Baptist Medical Center
Jacksonville, Florida, United States, 32207
2
Grady Memorial Hospital/Emory University
Atlanta, Georgia, United States, 30303
3
Montefiore Medical Center
The Bronx, New York, United States, 10467
4
La Sagrada Familia Clinic
José Hernández, Argentina