Blood Loss, Surgical
Conditions
Keywords
Viscoelastic testing, Coagulation, Quantra, Hemostasis
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTQuantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Sponsors
HemoSonics LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is ≥ 18 years * Subject is scheduled for cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device. * Subject is willing to participate, and he/she has signed a consent form.
Exclusion criteria
* Subject is younger than 18 years * Subject is unable to provide written informed consent * Subject is incarcerated at the time of the study * Subject is pregnant * Subject is currently enrolled in a distinct study that might confound the results of the proposed study * Subject is affected by a condition that, in the opinion of the clinical team, may pose additional risks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Quantra Clot Time results to TEG R results | Baseline, defined as after induction of anesthesia but before surgical incision | Coagulation function assessed by Quantra and TEG 5000 |
| Comparison of Quantra Clot Stiffness results to TEG MA results | Baseline, defined as after induction of anesthesia but before surgical incision | Coagulation function assessed by Quantra and TEG 5000 |
| Comparison of Quantra Clot Time results to standard coagulation test results (aPTT) | Baseline, defined as after induction of anesthesia but before surgical incision | Coagulation function assessed by Quantra and standard coagulation tests |
| Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results | Baseline, defined as after induction of anesthesia but before surgical incision | Coagulation function assessed by Quantra and standard coagulation tests |
| Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count | Baseline, defined as after induction of anesthesia but before surgical incision | Coagulation function assessed by Quantra and standard coagulation tests |
Countries
United States
Outcome results
None listed