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| Name | Class |
|---|---|
| University of Virginia | OTHER |
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The Quantraâ„¢ System is a novel point-of-care diagnostic device designed to perform whole blood coagulation analysis. This study compares Quantra measurements determined in arterial versus venous blood samples obtained from patients undergoing cardiac surgery.
The Quantra System is a fully integrated and automated in vitro diagnostic device which utilizes SEER Sonorheometry, an ultrasound-based technology, to characterize the dynamic changes in the viscoelastic properties of a blood sample during coagulation and clot lysis. Viscoelastic testing performed using existing technologies is typically performed on arterial samples obtained from patients undergoing surgical procedures, although reference ranges for these tests have been established for venous blood only.
The aim of this study is to evaluate potential differences between Quantra measurements determined in arterial versus venous blood samples obtained from patients undergoing cardiac surgery.
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Clot Time and Clot Stiffness results between arterial and venous samples | Coagulation function assessed by Quantra at 2 time points (Baseline and either during cardiac bypass or post-bypass) | Up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Quantra results to standard coagulation test results in venous samples | Coagulation function assessed by Quantra and standard coagulation tests at 2 time points (Baseline and either during cardiac bypass or post-bypass) | Up to 24 hours |
| Comparison of Quantra results to comparable ROTEM results in venous samples |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Coagulation function assessed by Quantra and ROTEM at 2 time points (Baseline and either during cardiac bypass or post-bypass) |
| Up to 24 hours |