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| Name | Class |
|---|---|
| University of California, Irvine | OTHER |
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This is a prospective, observational exploratory study of the performance of the Quantra System in adult patients that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure.
Patients 18 years or older that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure will be enrolled in this prospective, observational exploratory study. From each enrolled subject, blood samples will be collected at multiple time points for analysis on the Quantra QPlus or QStat Cartridge in parallel with other assessments performed as standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECMO Patients | Patients undergoing an ECMO 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 standard coagulation test results. | Coagulation function assessed by Quantra and standard-of-care coagulation tests | At the start of ECMO (considered the Baseline timepoint) |
| Comparison of Quantra Clot Stiffness results to standard coagulation test results. | Coagulation function assessed by Quantra and standard-of-care coagulation tests | At the start of ECMO (considered the Baseline timepoint) |
| Comparison of Quantra Clot Time results to standard coagulation test results. | Coagulation function assessed by Quantra and standard-of-care coagulation tests | 6 hours after the previous measurment |
| Comparison of Quantra Clot Stiffness results to standard coagulation test results. | Coagulation function assessed by Quantra and standard-of-care coagulation tests | 6 hours after the previous measurment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure. Both COVID-19 and non-COVID-19 related ECMO patients will be enrolled
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Irvine | California | 92697 | United States |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| D002318 | Cardiovascular Diseases |