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This pilot study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients.
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 patient population. 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trauma patients | Subject experiencing major trauma such that viscoelastic testing is performed as standard of care to assess coagulopathy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantra System | Diagnostic Test | Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the Quantra Clot Time results to standard coagulation test results | Coagulation function assessed by Quantra and standard coagulation tests | Upon arrival to emergency department |
| Comparison of the Quantra Clot Stiffness results to standard coagulation test results | Coagulation function assessed by Quantra and standard coagulation tests | Upon arrival to emergency department |
| Comparison of the Quantra Clot Time results to ROTEM Delta results | Coagulation function assessed by Quantra and ROTEM delta | Upon arrival to emergency department |
| Comparison of the Quantra Clot Stiffness results to ROTEM Delta results | Coagulation function assessed by Quantra and ROTEM delta | Upon arrival to emergency department |
| Comparison of the Quantra Fibrinolysis results to ROTEM Delta results | Coagulation function assessed by Quantra and ROTEM delta | Upon arrival to emergency department |
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Inclusion Criteria:
Exclusion Criteria:
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Potential study participants will be adult (>18 years) trauma patients where visicoelastic testing is performed as standard of care to assess coagulopathy.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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