Direct-to-angio Approach From loCal hOspitals Based on a PoInt-of-care bLOod Test for LVO
ConditionAcute Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorJuan Vicenty
About this trial
Direct-to-angio approach from loCal hOspitals based on a PoInt-of-care bLOod Test for LVO (COPILOT) is a multi-center, prospective, cluster-randomized crossover trial that will evaluate if the triage assessment to thrombectomy puncture time is shorter after performing the LVOne testing compared to current management standards in patients with suspected large vessel occlusion.
Eligibility criteria
Qualifiers
Age: 21 to 85 years old
Language: Speak and understand Spanish or English
Residence: Resident of Puerto Rico
Clinical presentation: Suspected acute stroke
Disqualifiers
Already assessed at another hospital, and ambulance admission is a transfer for continuing care OR
Received thrombolysis therapy before consent (e.g., tPA, alteplase)
Medical History: diagnosed with any of the following in the past 4 weeks: deep vein thrombosis (DVT), pulmonary embolism (PE), arterial embolism, stroke, transient ischemic attack (TIA), long bone fracture, major trauma, surgery under general anesthesia, or head injury requiring hospital admission within the last 4 weeks.
Modified Rankin Scale: Pre-stroke mRS ≥ 3
Trial design
Treatments tested in this trial
- Diagnostic standard of care
- LVOne Test
Treatment groups
520 Participants
are divided into 2 treatment groupsSponsors and collaborators
Juan Vicenty
Lead sponsor
University of Puerto Rico
Sponsor institution
University of Puerto Rico
Collaborator
Mennonite Health System
Collaborator
Source ClinicalTrials.gov