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

Recruiting

Who can join

Ages 18 and older · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Philips Clinical & Medical Affairs Global · Participants: 594 · Started: Jun 23, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04701684

Locations in the U.S.

FloridaBaptist Medical Center, Jacksonville
GeorgiaGrady Memorial Hospital/Emory University, Atlanta (Not yet recruiting)
New YorkMontefiore Medical Center, The Bronx

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.