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This study will establish reference range intervals for the Quantra System, a next-generation diagnostic platform that provides whole blood coagulation testing at the point-of-care.
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 Quantra Surgical Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system. In this multi-center, prospective, observational study, blood samples will be obtained from healthy adult volunteers to establish a normal reference range for the test parameters measured by the Quantra System.
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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, Heparinase Clot Time, Clot Stiffness, Fibrinogen Contribution and Platelet Contribution on the Quantra System | Reference range intervals determined in this study from the analysis of blood samples collected from healthy adults will serve as the initial reference ranges for the Quantra test parameters when the Surgical Cartridge is commercially available. | Baseline, determined from 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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| Name | Affiliation | Role |
|---|---|---|
| Julia Warren-Ulanch, MD | Creedmoor Centre Endocrinology | Principal Investigator |
| Charles Greenberg, MD | Medical University of South Carolina | Principal Investigator |
| Kenichi Tanaka, MD | University of Maryland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States | ||
| Creedmoor Centre Endocrinology |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Raleigh |
| North Carolina |
| 27615 |
| United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |