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| Name | Class |
|---|---|
| IRCCS Policlinico S. Donato | OTHER |
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This study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests in cardiac surgery patients. In addition the association of Quantra-derived parameters with select platelet function tests will be investigated.
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 (previously called the Surgical Cartridge), was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge provides six parameters that depict the functional status of a patient's coagulation system.
This single site, prospective observational study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests (PT, aPTT, fibrinogen, platelet count) in cardiac surgery patients. As an additional exploratory study, the association of Quantra-derived parameters with select platelet function tests will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac surgery patients | Patients undergoing elective cardiac surgery requiring cardiopulmonary bypass. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quantra System with the QPlus Cartridge | Diagnostic Test | Point-of-care viscoelastic testing |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta results | Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta | Baseline (before surgery) |
| Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta | Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta | After cardiac bypass (10 minutes after administration of protamine) |
| Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results | Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests | Baseline (before surgery) |
| Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results | Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests | After cardiac bypass (10 minutes after administration of protamine) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest | Platelet function assessed by Quantra QPlus Cartridge and MEA | Baseline (before surgery) |
| Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest |
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Inclusion Criteria:
Exclusion Criteria:
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The study population includes subjects 18 years or older undergoing cardiac surgery with cardiopulmonary bypass.
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| Name | Affiliation | Role |
|---|---|---|
| Marco Ranucci, MD | IRCCS Policlinico San Donato (Milan) Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Policlinico San Donato | Milan | Italy |
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| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
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Platelet function assessed by Quantra QPlus Cartridge and MEA |
| After cardiac bypass (10 minutes after administration of protamine) |
| D006425 |
| Hemic and Lymphatic Diseases |