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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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • Diagnostic standard of care

    Diagnostic test

    Participants will receive the diagnostic standard of care: standard laboratory workup, non-contrast brain CT, brain CTA, brain CTP, or brain MRI.

  • LVOne Test

    Diagnostic test

    Participants will receive the LVOne test, which will measure D-dimer and Glial Fibrillary Acidic Protein (GFAP) levels to diagnose acute stroke.

Treatment groups

520 Participants
are divided into 2 treatment groups
Group A: Standard of CareActive comparator 1 intervention
Group B: LVOne TestExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in the time from triage assessment to thrombectomy puncture

The difference in time from the participant triage assessment to thrombectomy puncture.

Time frame
24 hours

Secondary outcomes

1

Time from spoke hospital triage assessment to LVOne test in intervention

Difference in time from triage assessment to the performance of the LVOne test in the intervention group.

Time frame
24 hours
2

Time from HUB hospital triage assessment to LVOne test in intervention

The difference in time from the HUB hospital triage assessment to the performance of the LVOne test.

Time frame
24 hours
3

Time from HUB hospital triage assessment to thrombectomy puncture

The difference in time from the HUB hospital triage assessment to the thrombectomy puncture.

Time frame
24 hours
4

Thrombectomy rate (proportion of treated LVO)

The number of participants that received thrombectomy.

Time frame
24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Juan Vicenty

Lead sponsor

University of Puerto Rico

Sponsor institution

University of Puerto Rico

Collaborator

Mennonite Health System

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: