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This study will assess the clinical performance of the Quantra System with the QStat Cartridge in the liver transplant population.
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 propoerties of a whole blood sample during coagulation. The Quantra QStat Cartridge was developed to monitor hemostasis in the trauma and liver transplant populations which may experience a range of coagulopathies of various etiologies including fibrinolytic defects.
This single-center, prospective, observational stuey will evaluate the performance of the Quantra System with the QStat Cartridge as compared to corresponding measures determined using the TEG 5000.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver transplant patients | Adult patients undergoing deceased donor liver transplantation. |
|
| 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, 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, after induction of anesthesia, before surgical incision |
| Comparison of Quantra Clot Lysis results to TEG LI30 results | Coagulation function assessed by Quantra and TEG 5000 | Baseline, after induction of anesthesia, before surgical incision |
| Comparison of Quantra Clot 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 Lysis results to TEG LI30 results | Coagulation function assessed by Quantra and TEG 5000 | During surgery |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes subjects 18 years or older undergoing deceased donor liver transplant.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | 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 |