Trauma Clinical Trial
Official title:
Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Obstetric Hemorrhage
This pilot study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients or patients with OB hemorrhage.
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 QStat Cartridge was developed to
monitor hemostasis in patients that may experience a range of coagulopathies of various
etiologies including fibrinolytic defects. These patients include the trauma and obstetric
hemorrhage populations. The cartridge consists of four independent channels each containing
different sets of reagents, which provide four measurements performed in parallel yielding
five parameters that depict the functional status of a patient's coagulation system.
This single-center, prospective, observational pilot study will evaluate the performance of
the Quantra System with the QStat Cartridge as compared to standard coagulation tests and
comparable measures using conventional viscoelastic testing methods.
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