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Evaluation of a Point-of-care Lateral Flow Assay in Glial Fibrillary Acidic Protein (GFAP) and D-dimer in Diagnosis of Large Vessel Occlusion Acute Ischemic Stroke in a Pediatric Hospital

ConditionsStroke CodeLarge Vessel OcclusionAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-21
SponsorBoston Children's Hospital

About this trial

The goal of this study is to test the efficacy of a rapid bedside blood test in determining if a stroke is happening in children who present to the emergency department with stroke symptoms. The main questions it aims to answer are:

* To determine the sensitivity of detecting a large vessel occlusion (LVO) as the etiology of acute ischemic stroke (AIS) in a pediatric population using a point-of-care blood-based assay (LVOne). * To determine the positive predictive value (PPV) of LVOne in a pediatric population

Participants will:

* Provide a small sample of blood to be used to test the accuracy of the device. * Participants will still receive all standard of care work-up for stroke, which could include computed tomography/magnetic resonance imaging (CT/MRI).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Presenting with acute onset (<18 hours) spontaneous (no trauma) focal neurologic deficit or altered consciousness

Disqualifiers

Participants with surgery in the past month

Participants with known trauma in the past month

Participants with known seizure history or anti-seizure medications

Participants who are adults with decisional impairment

Trial population

Participants will be included if they present to Boston Children's Hospital Emergency Department and present with justification of activating a code stroke, such as acute onset spontaneous focal neurologic deficit or altered consciousness.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • Point of Care Rapid Assay

    Device

    In this study, participants will provide a small sample of blood to test the accuracy and efficacy of the Rapid Assay device. Standard of care for diagnosis will follow, regardless of Assay outcomes.

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: Stroke code patients in BCH ED1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity of Device

To determine the sensitivity of detecting an large vessel occlusion as the etiology of acute ischemic stroke.

Time frame
From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).

Secondary outcomes

1

Positive Predictive Value

To determine the Positive Predictive Value of LVOne for any imaging-confirmed acute ischemic stroke

Time frame
From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).
2

Positive Predictive Value of Large Vessel Occulusion

To determine the Positive Predictive Value of LVOne for acute ischemic stroke with large vessel occlusion

Time frame
From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).
3

Specificity of device for stroke

To determine the specificity of LVOne for any imaging-confirmed acute ischemic stroke

Time frame
From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).
4

Frequency of indeterminate results

To identify the frequency of indeterminate readout on LVOne assay

Time frame
From enrollment in study in the emergency department through completion of the diagnostic evaluation for stroke during the index ED visit (approximately up to 24 hours).

Other outcomes

Sponsors and contacts

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

Boston Children's Hospital

Lead sponsor

Source ClinicalTrials.gov

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