Reference Range Study for the Quantra Analyzer With the Quantra Surgical Cartridge

Study Overview
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Brief Summary
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This study will establish reference range intervals for the Quantra System, a next-generation diagnostic platform that provides whole blood coagulation testing at the point-of-care.

Detailed Description
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The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra Surgical Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system. In this multi-center, prospective, observational study, blood samples will be obtained from healthy adult volunteers to establish a normal reference range for the test parameters measured by the Quantra System.

Official Title
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Reference Range Study for the Quantra Analyzer With the Quantra Surgical Cartridge

Conditions
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Coagulation

Intervention / Treatment
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* Diagnostic Test: Quantra System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is > 18 years Subject is willing to participate and he/she has signed a consent form Subject's laboratory coagulation test results at screening are within each test's normal reference range Exclusion Criteria: Subject is younger than 18 years Subject has a history of a coagulation disorder Subject is pregnant or lactating Subject is currently taking medications known to alter coagulation Subject had a blood transfusion or surgery within the last month Subject has one or more laboratory coagulation test result outside of the normal reference range at screening Drug abuse Excessive alcohol consumption Subject is unable to provide written informed consent Subject is incarcerated at the time of the study Subject previously participated in this study

Ages Eligible for Study
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Minimum Age: 18 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy Volunteers<br>Blood samples from healthy volunteers analyzed on the Quantra System. | Diagnostic Test: Quantra System<br>* Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.<br>* Other names: Quantra Surgical Cartridge;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reference range intervals for measurement of Clot Time, Heparinase Clot Time, Clot Stiffness, Fibrinogen Contribution and Platelet Contribution on the Quantra System | Reference range intervals determined in this study from the analysis of blood samples collected from healthy adults will serve as the initial reference ranges for the Quantra test parameters when the Surgical Cartridge is commercially available. | Baseline, determined from single blood draw |