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The objective is to determine the reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.
This is a multicenter, prospective, observational study of a healthy adult population with normal coagulation function to determine the reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge. The threshold for the Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | Blood samples from healthy volunteers analyzed on the Quantra System. |
|
| 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 |
|---|---|---|
| Reference range intervals for measurement of Clot Time (CT) parameter | Reference range intervals determined in this study will serve as the reference range for CT on the QStat Cartridge when it is commercially available. | Baseline, determined from a single blood draw |
| Reference range intervals for measurement of Clot Stiffness (CS) parameter | Reference range intervals determined in this study will serve as the reference range for CS on the QStat Cartridge when it is commercially available. | Baseline, determined from a single blood draw |
| Reference range intervals for measurement of Fibrinogen Contribution to Clot Stiffness (FCS) parameter | Reference range intervals determined in this study will serve as the reference range for FCS on the QStat Cartridge when it is commercially available. | Baseline, determined from a single blood draw |
| Reference range intervals for measurement of Platelet Contribution to Clot Stiffness (PCS) parameter | Reference range intervals determined in this study will serve as the reference range for PCS on the QStat Cartridge when it is commercially available. | Baseline, determined from a single blood draw |
| Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter | Reference range intervals determined in this study will serve as the reference range for CSL on the QStat Cartridge when it is commercially available. | Baseline, determined from a single blood draw |
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Inclusion Criteria:
Exclusion Criteria:
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Adult volunteers with normal coagulation function, approximately equal numbers of males and females across three age group categories (18-30, 31-50 and >50 years). The racial and ethnic profiles will be representative of the populations at each site.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WR-Mount Vernon Clinical Research, LLC | Sandy Springs | Georgia | 30328 | United States | ||
| M3 Wake Research |
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| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
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| Raleigh |
| North Carolina |
| 27612 |
| United States |
| WR-ClinSearch, LLC | Chattanooga | Tennessee | 37421 | United States |
| D006425 |
| Hemic and Lymphatic Diseases |