Trauma Clinical Trial
Official title:
Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Obstetric Hemorrhage
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients and obstetric patients with postpartum 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. This includes the trauma, obstetric hemorrhage and
liver transplant 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 prospective, observational pilot study will evaluate the performance of the Quantra
System with the QStat Cartridge as compared to comparable measures using conventional
viscoelastic testing methods.
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