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.
Study Type
OBSERVATIONAL
Enrollment
30
Point-of-care viscoelastic testing
IRCCS Policlinico San Donato
Milan, Italy
Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta results
Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: After cardiac bypass (10 minutes after administration of protamine)
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
Time frame: Baseline (before surgery)
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
Time frame: After cardiac bypass (10 minutes after administration of protamine)
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