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.
Study Type
OBSERVATIONAL
Enrollment
30
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Texas Tech University Health Sciences Center El Paso
El Paso, Texas, United States
Comparison of Quantra Clot Time and Clot Stiffness results to standard coagulation test results
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: Upon arrival to emergency department (trauma subjects) or upon presentation with obstetric hemorrhage, prior to the administration of blood products or antifibrinolytics in parallel with samples collected for routine ROTEM analysis and laboratory assays
Comparison of Quantra Clot Time and Clot Stiffness results to ROTEM Delta results
Coagulation function assessed by Quantra and ROTEM Delta
Time frame: Upon arrival to emergency department (trauma subjects) or upon presentation with OB hemorrhage, prior to the administration of blood products or antifibrinolytics in parallel with samples collected for routine ROTEM analysis and laboratory assays
Comparison of Quantra Fibrinolysis results to ROTEM Delta results
Coagulation function assessed by Quantra and ROTEM Delta
Time frame: Upon arrival to emergency department (trauma subjects) or upon presentation with OB hemorrhage, prior to the administration of blood products or antifibrinolytics in parallel with samples collected for routine ROTEM analysis and laboratory assays
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