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This study will monitor coagulation parameters during the perioperative course of cancer surgical procedures using the Quantra System with the QPlus Cartridge.
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 iin parallel yielding six parameters that depict the functional status of a patient's coagulation system.
The oncologic surgical population presents unique challenges to providers who must distinguish between a cancer patient's increased tendency toward both thrombosis and hemorrhage. This single site prospective observational study in oncologic patients will give an insight into the coagulation status of critically ill cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer surgery patients | Adult subjects (18 years or older) undergoing an oncologic surgical procedure. |
|
| 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, 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, before surgical incision |
| Comparison of Quantra Time results to TEG R results | Coagulation function assessed by Quantra and TEG 5000 | During surgery |
| Comparison of Quantra Clot Stiffness results to TEG MA results | Coagulation function assessed by Quantra and TEG 5000 | During surgery |
| Comparison of Quantra Clot Time results to TEG R results | Coagulation function assessed by Quantra and TEG 5000 | Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery |
| Comparison of Quantra Clot Stiffness results to TEG MA results | Coagulation function assessed by Quantra and TEG 5000 | Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes adult subjects undergoing an oncologic surgical procedure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | 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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| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |