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Device
DTAS Workflow vs Standard Triage for Stroke Treatment
N/A
Recruiting
Led By Marc Ribo
Research Sponsored by Philips Healthcare
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects with no significant pre-stroke functional disability (modified Rankin scale 0 - 2)
Endovascular treatment team immediately available (Neurologist, Neurointerventionist, Anesthesiologist, Nursing, Technicians as per local standard practice)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up peri-procedural time
Awards & highlights
Study Summary
This trial will compare the outcomes of stroke patients who receive care using the DTAS workflow with those who receive care using the standard workflow.
Who is the study for?
The WE-TRUST trial is for adults who've had a stroke, can give consent, and have no major disability from past strokes. They must arrive at the hospital within 6 hours of their stroke starting and have a certain severity score on a neurological scale. People with in-hospital strokes, severe conditions or high blood pressure not suitable for thrombolysis, pregnant women, Philips employees and their families are excluded.Check my eligibility
What is being tested?
This study compares two ways to decide treatment for stroke patients: one group goes straight to an imaging suite that uses special CBCT technology (DTAS), while the other follows traditional CT/MR scans. The goal is to see which method leads to better outcomes after the stroke.See study design
What are the potential side effects?
Since this trial focuses on workflow rather than medication or devices, side effects aren't typical as in drug trials. However, there may be risks associated with standard treatments following imaging like allergic reactions to contrast media used during angiography.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was independent in daily activities before my stroke.
Select...
A team of specialists is ready to treat me if needed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 ± 14 days follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 ± 14 days follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Distribution of ordinal modified Rankin Scale (mRS) scores at 90 ± 14 days follow-up
Secondary outcome measures
Distribution of ordinal modified Rankin Scale (mRS) scores
Median time measurements (door-to-arterial puncture time)
Median time measurements (door-to-reperfusion time)
Other outcome measures
Exploratory: Degree of disability (other clinical outcome)
Exploratory: Dichotomized mRS score (other clinical outcome)
Exploratory: Dramatic early favorable response (other clinical outcome)
+28 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Direct tot Angiography Suite (DTAS) triage workflowExperimental Treatment1 Intervention
Group II: Conventional CT/MR triage workflowActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Philips HealthcareLead Sponsor
125 Previous Clinical Trials
281,762 Total Patients Enrolled
1 Trials studying Stroke
28 Patients Enrolled for Stroke
Philips Clinical & Medical Affairs GlobalLead Sponsor
49 Previous Clinical Trials
15,974 Total Patients Enrolled
2 Trials studying Stroke
183 Patients Enrolled for Stroke
Marc RiboPrincipal InvestigatorVall d'Hebron University Hospital, Barcelona
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor expects I have less than one year to live due to my illness.I do not have bleeding disorders or take blood thinners with INR over 3.0.You have had a severe allergic reaction to contrast dye in the past.I have been diagnosed with inflammation of the brain's blood vessels.Your initial NIHSS score before joining the study needs to be 10 points or more.Your blood sugar level is less than 50mg/dL before starting the study.Your platelet count is less than 30,000 per microliter before starting the study.I did not have seizures when my stroke started.I am not in a coma or totally unresponsive.My mental and physical health does not significantly interfere with my daily activities.I suspect I'm having a stroke and can get to a stroke center within 6 hours from when my symptoms started.You had a stroke while in the hospital.I was independent in daily activities before my stroke.My CT/MR from another hospital is accepted by my current doctor.You are very restless or upset.I experience severe vomiting.I am 18 or older, or of legal age to consent where I live.I have very high blood pressure and am receiving clot-dissolving treatments.I need urgent care to support my life due to my unstable condition.I am pregnant.A team of specialists is ready to treat me if needed.
Research Study Groups:
This trial has the following groups:- Group 1: Conventional CT/MR triage workflow
- Group 2: Direct tot Angiography Suite (DTAS) triage workflow
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are any participants being taken in for this experiment currently?
"Clinicaltrials.gov indicates that this medical experiment is actively seeking participants, with its initial post-date being June 23rd 2021 and the last edit on October 24th 2022."
Answered by AI
Could you provide an estimate of the total participants involved in this trial?
"To run this trial, Philips Healthcare needs 564 participants who meet the outlined criteria. To complete recruitment, they are utilizing medical centres like University of Massachusetts in Worcester and Baptist Medical Center in Jacksonville."
Answered by AI
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