Coagulation Clinical Trial
Official title:
Reference Range Study for the Quantra Analyzer With the Quantra Surgical Cartridge
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.
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. ;
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