BridgeMD
New treatment option for Stroke, Acute
Official title WE-TRUST (Workflow Optimization to Reduce Time to Endovascular Reperfusion for Ultra-fast Stroke Treatment)
ClinicalTrials.gov ID: NCT04701684
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- people with no significant pre-stroke functional disability (modified Rankin scale 0 - 2).
- people suspected of acute ischemic stroke with an estimated arrival time at a stroke center (clinical investigational site participating in this...
- Informed consent obtained from patient or his or her legally designated representative (if locally required).
You likely can't join if
- 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...
- 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...
See the full eligibility 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.
- people with no significant pre-stroke functional disability (modified Rankin scale 0 - 2).
- people 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...
- 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)
- 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...
- 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...
- 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 assigned by chance only in case an NIHSS is...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- The Bronx, New York, United States
- José Hernández, Argentina
- Brussels, Belgium
- Fortaleza, Brazil
- São José do Rio Preto, Brazil
- Vitória, Brazil
- Lyon, France
- Montpellier, France
- Paris, France
- Bonn, Germany
- Kassel, Germany
- Lübeck, Germany
- Munich, Germany
- Nieuwegein, Netherlands
- The Hague, Netherlands
- Bucharest, Romania
- Madrid, Moncloa - Aravaca, Spain
- Barcelona, Spain
+ 3 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States; Atlanta, Georgia, United States; The Bronx, New York, United States; José Hernández, Argentina; Brussels, Belgium; Fortaleza, Brazil and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.