This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra QPlus Cartridge in patients undergoing cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.
The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, and 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 in parallel yielding six parameters that depict the functional status of a patient's coagulation system. This single-center, prospective, observational study will evaluate the performance of the Quantra System as compared to and comparable measures determined using the TEG 5000.
Study Type
OBSERVATIONAL
Enrollment
30
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
University of Texas Medical Branch
Galveston, Texas, United States
Comparison of Quantra Clot Time results to TEG R results
Coagulation function assessed by Quantra and TEG 5000
Time frame: Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Stiffness results to TEG MA results
Coagulation function assessed by Quantra and TEG 5000
Time frame: Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Time results to TEG R results
Coagulation function assessed by Quantra and TEG 5000
Time frame: During bypass
Comparison of Quantra Clot Stiffness results to TEG MA results
Coagulation function assessed by Quantra and TEG 5000
Time frame: During bypass
Comparison of Quantra Clot Time results to TEG R results
Coagulation function assessed by Quantra and TEG 5000
Time frame: Post-bypass, defined as 10 to 20 minutes after protamine administration
Comparison of Quantra Clot Stiffness results to TEG MA results
Coagulation function assessed by Quantra and TEG 5000
Time frame: Post-bypass, defined as 10 to 20 minutes after protamine administration
Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: Baseline, defined as after induction of anesthesia but before surgical incision
Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: During bypass
Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: During bypass
Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: During bypass
Comparison of Quantra Clot Time results to standard coagulation test results (aPTT)
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: Post-bypass, defined as 10 to 20 minutes after protamine administration
Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: Post-bypass, 10 to 20 minutes after protamine
Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count
Coagulation function assessed by Quantra and standard coagulation tests
Time frame: Post-bypass, defined as 10 to 20 minutes after protamine administration