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This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.
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 QPlus 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.
This single-site, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using TEG in patients taking antiplatelet medication that are scheduled to undergo cardiac surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Surgery Patients | Patients taking antiplatelet medication who are scheduled for elective cardiac surgery. |
|
| 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 Quantra Clot Time test results to TEG test results. | Coagulation function assessed by Quantra and TEG. | Prior to surgery (Baseline) |
| Comparison of Quantra Clot Stiffness test results to TEG test results. | Coagulation function assessed by Quantra and TEG. | Prior to surgery (Baseline) |
| Comparison of Quantra Clot Time and Clot Stiffness test results to TEG test results. | Coagulation function assessed by Quantra and TEG. | Post-bypass (10 to 20 minutes after protamine administration). |
| Comparison of Quantra Clot Time test results to TEG test results. | Coagulation function assessed by Quantra and TEG. | Post-bypass (10 to 20 minutes after protamine administration). |
| Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen | Coagulation function assessed by Quantra and laboratory fibrinogen testing | Prior to surgery (Baseline) |
| Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen | Coagulation function assessed by Quantra and laboratory fibrinogen testing | Post-bypass (10 to 20 minutes after protamine administration). |
| Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count |
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Inclusion Criteria:
Exclusion Criteria:
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Potential study participants will be adult (≥ 18 years) subjects who are taking antiplatelet medication and who are scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsville Hospital | Huntsville | Alabama | 35801 | United States |
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| ID | Term |
|---|---|
| D016063 | Blood Loss, Surgical |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |
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Coagulation function assessed by Quantra and laboratory fibrinogen testing
| Post-bypass (10 to 20 minutes after protamine administration). |
| Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count | Coagulation function assessed by Quantra and platelet count | Prior to surgery (Baseline) |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |