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This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra QPlus Cartridge in patients undergoing cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, and 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-center, prospective, observational study will evaluate the performance of the Quantra System as compared to and comparable measures determined using the TEG 5000.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Surgery Patients | Patients undergoing cardiopulmonary bypass surgery, including placement of a ventricular access device. |
|
| 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 results to TEG R results | Coagulation function assessed by Quantra and TEG 5000 | Baseline, defined as after induction of anesthesia but before surgical incision |
| Comparison of Quantra Clot Stiffness results to TEG MA results | Coagulation function assessed by Quantra and TEG 5000 | Baseline, defined as after induction of anesthesia but before surgical incision |
| Comparison of Quantra Clot Time results to TEG R results | Coagulation function assessed by Quantra and TEG 5000 | During bypass |
| Comparison of Quantra Clot Stiffness results to TEG MA results | Coagulation function assessed by Quantra and TEG 5000 | During bypass |
| Comparison of Quantra Clot Time results to TEG R results | Coagulation function assessed by Quantra and TEG 5000 | Post-bypass, defined as 10 to 20 minutes after protamine administration |
| Comparison of Quantra Clot Stiffness results to TEG MA results | Coagulation function assessed by Quantra and TEG 5000 | Post-bypass, defined as 10 to 20 minutes after protamine administration |
| Comparison of Quantra Clot Time results to standard coagulation test results (aPTT) | Coagulation function assessed by Quantra and standard coagulation tests |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes subjects 18 years or older undergoing cardiac surgery utilizing cardiopulmonary bypass, including placement of a ventricular access device.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch | Galveston | Texas | 77555 | 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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| Baseline, defined as after induction of anesthesia but before surgical incision |
| Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results | Coagulation function assessed by Quantra and standard coagulation tests | Baseline, defined as after induction of anesthesia but before surgical incision |
| Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count | Coagulation function assessed by Quantra and standard coagulation tests | Baseline, defined as after induction of anesthesia but before surgical incision |
| Comparison of Quantra Clot Time results to standard coagulation test results (aPTT) | Coagulation function assessed by Quantra and standard coagulation tests | During bypass |
| Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results | Coagulation function assessed by Quantra and standard coagulation tests | During bypass |
| Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count | Coagulation function assessed by Quantra and standard coagulation tests | During bypass |
| Comparison of Quantra Clot Time results to standard coagulation test results (aPTT) | Coagulation function assessed by Quantra and standard coagulation tests | Post-bypass, defined as 10 to 20 minutes after protamine administration |
| Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results | Coagulation function assessed by Quantra and standard coagulation tests | Post-bypass, 10 to 20 minutes after protamine |
| Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count | Coagulation function assessed by Quantra and standard coagulation tests | Post-bypass, defined as 10 to 20 minutes after protamine administration |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |