QPlus Pediatric Reference Interval

Study Overview
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Brief Summary
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Evaluation of coagulation results reported by the Qplus Quantra System to determine pediatric reference range intervals.

Detailed Description
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Single center observational study of the pediatric patient population (< 18yrs) with normal coagulation function to determine the reference range interval for the clotting parameters reported by the Quantra QPlus system.

Official Title
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Evaluation of a Pediatric Reference Interval Using QPLUS System

Conditions
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Pediatric ALL, Healthy

Intervention / Treatment
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* Device: Diagnostic Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: <18yrs Scheduled for procedure requiring anesthesia Access to blood sampling Consented Exclusion Criteria: >18yrs of age pre-term babies patients with know hematological disorders Difficult to obtain blood sampling Has received a blood product transfusion within the last 24hrs. Legal guardian unwilling to consent

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Diagnostic Test|Diagnostic device to monitor coagulation properties of a whole blood sample at the point of care|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reference range interval for measurement of clot time (CT) parameter | Reference range interval determined in this study will serve as the reference for CT results in this particular population | Baseline, after access placement before any procedures | 
| Reference range interval for measurement of clot time (CTH) parameter | Reference range interval determined in this study will serve as the reference for CTH results in this particular population | Baseline, after access placement before any procedures | 
| Reference range interval for measurement of clot stiffness (CS) parameter | Reference range interval determined in this study will serve as the reference for CS results in this particular population | Baseline, after access placement before any procedures | 
| Reference range interval for measurement of Fibrinogen Contribution to clot stiffness (FCS) parameter | Reference range interval determined in this study will serve as the reference for FCS results in this particular population | Baseline, after access placement before any procedures | 
| Reference range interval for measurement of Platelet Contribution to clot stiffness (PCS) parameter | Reference range interval determined in this study will serve as the reference for PCS results in this particular population | Baseline, after access placement before any procedures | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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QPlus, Quantra, Pediatric, Reference Range