Evaluation of Direct Transfer to Angiography Suite vs. Computed Tomography Suite in Endovascular Treatment: Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 174
- Locations
- 2
- Primary Endpoint
- Clinical outcome measurde by modified Rankin Scale score (shift analysis)
Study Overview
Brief Summary
To evaluate the hypothesis that an ultra-fast triage with one-stop in angiography suite based on cone-beam CT compared to traditional protocol offers a better outcome in the distribution of the modified Rankin Scale scores at 90 days in acute ischemic stroke patients with suspected large vessel occlusion (LVO) within 6 hours from symptoms onset.
Detailed Description
Prospective, randomized, open, treatment-blinded trial of acute stroke patients with suspected large vessel occlusion within 6 hours from symptoms onset in which two strategies will be compared: Direct Transfer to Angiography Suite (DTAS) vs. Computed Tomography Suite (DTCT). The study will be unicentric however there is the possibility of incorporating new stroke centers with previous experience of at least 50 DTAS cases.
The RACE scale (Rapid Arterial oCclusion Evaluation) will be used as a prehospital screening tool to identify acute stroke patients with suspicion of LVO. Once prenotifying the imminent arrival and the verified inclusion and exclusion criteria by the Neurologist at arrival, the patient will be randomized by an app in one of both study protocols.
Subjects will be followed up to 90 days post-randomization.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Large vessel occlusion suspected acute stroke codes (RACE>4) within 6 hours from stroke onset which are prenotified from emergency medical system.
- •Confirmed NIHSS>10 at arrival.
- •Good pre-stroke functional status (mRS≤2)
- •Angiography suite available.
- •Endovascular treatment team available (Neurologist, Interventionist, anesthesiologist, Nursery, Technicians...)
Exclusion Criteria
- •Hemodynamically unstable patients who requires of advanced vital support.
- •Patients with an advanced disease that conditions a life expectancy lower than 6 months.
- •Participation in other clinical trial with a drug or device which could influence in the outcome.
- •Patients with neurological or psychiatric disease that could confound future evaluations.
- •Lack of disponibility for 90 days tracing.
Outcomes
Primary Outcomes
Clinical outcome measurde by modified Rankin Scale score (shift analysis)
Time Frame: 90 days
Modified Rankin Scale score in ischemic stroke patients with large vessel occlusion as evaluated through a structured telephone-based interview performed by a central assessor who is blinded to group assignment. Modified Rankin Scale measures functional status with a range from 0 (asymptomatic) to 6 (dead).
Rate of patients with treatment associated complications.
Time Frame: 72 hours
Lack of treatment associated complications, mainly hemorrhagic transformation.
Secondary Outcomes
- Rate of patients treated by endovascular treatment(8 hours)
- Delay of inhospital times(8 hours)
- Rate of dramatic improvement(24 hours)
- Rate of good functional outcome(90 days)
Investigators
Manuel Requena Ruiz
Principal Investigator
Hospital Vall d'Hebron