Status:
NOT_YET_RECRUITING
Direct-to-angio Approach From loCal hOspitals Based on a PoInt-of-care bLOod Test for LVO
Lead Sponsor:
Juan Vicenty
Collaborating Sponsors:
University of Puerto Rico
Mennonite Health System
Conditions:
Acute Stroke
Eligibility:
All Genders
21-85 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
The COPILOT trial utilizes a cluster randomized crossover design within the Sistema de Salud Menonita (SSM) hospital network to evaluate if early detection of large vessel occlusion (LVO) stroke with ...
Eligibility Criteria
Inclusion
- Age: 21 to 85 years old
- Language: Speak and understand Spanish or English
- Residence: Resident of Puerto Rico
- Clinical presentation: Suspected acute stroke
- Time of presentation: Monday to Friday, between 8:00 a.m. and 4:00 p.m.
- Time of symptom onset: symptoms are known to have begun within the last 6 hours, OR last known to be well between 6 and 18 hours ago, confirmed by a reliable witness or healthcare professional
Exclusion
- Previous healthcare encounter:
- 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
- The patient is a pregnant woman
- The patient is under legal custody or deprived of liberty in penitentiary institutions
- The patient is unable to provide informed consent on their own and whose authorized legal representatives are unavailable in person or by telephone during recruitment
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT06910163
Start Date
May 1 2025
End Date
August 1 2028
Last Update
April 4 2025
Active Locations (1)
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1
Hospital Menonita Caguas
Caguas, PR, Puerto Rico, 00725