No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
594 (estimated)
Sponsor
Philips Clinical & Medical Affairs Global · Industry
Who this trial is looking for
This trial is looking for adults who have had a stroke and can get to a stroke center quickly. Participants will receive treatment aimed at improving outcomes for stroke patients.
Are You a Good Fit for This Trial?
Rules you outSevere dementiaUnstable clinical status requiring life support
You may be able to join if
I am at least 18 years old.
I have a baseline NIHSS score of 10 or higher.
I have no significant pre-stroke disability.
I have symptoms of an acute ischemic stroke and arrived at a stroke center within 6 hours of symptom onset.
I have given my informed consent.
The angiography suite is immediately available.
The endovascular treatment team is ready to provide care.
You may not be able to join if
I have a known blood disorder or take anticoagulants with an INR over 3.0.
My platelet count is less than 30,000/μL.
My baseline blood glucose is less than 50 mg/dL.
I have severe, sustained hypertension that cannot be controlled.
I am in a coma or have extreme agitation.
I have had a stroke while in the hospital.
I have a severe allergy to contrast medium.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 Ran…
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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