Reference Range Study for the Quantra QStat System

Clinical Trial ID: NCT04219371

Description

The objective is to determine the reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.

This is a multicenter, prospective, observational study of a healthy adult population with normal coagulation functioj to determine the reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge. The threshold for the Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.


Criteria

Inclusion Criteria: - Subject is 18 years or older - Subject is willing to participate and 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 has one or more laboratory coagulation test restuls outside of the normal reference range at screening - Subject had a blood transfusion or surgery within the last month - Drug abuse - Excessive alcohol consumption - Subject is unable to provide written informed consent - Subject is incarcerated at the time of the study - Subect previously participated in this study

  • Start Date

    2020-01-07

  • Last Updated

    2020-02-11

  • Sponsor

    HemoSonics LLC

  • Condition Name

    Coagulation Disorder

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