HemoSonics - UTMB Cardiac Surgery Study
- Conditions
- Blood Loss, Surgical
- Interventions
- Diagnostic Test: Quantra System
- Registration Number
- NCT03988465
- Lead Sponsor
- HemoSonics LLC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cardiac Surgery Patients Quantra System Patients undergoing cardiopulmonary bypass surgery, including placement of a ventricular access device.
- Primary Outcome Measures
Name Time Method Comparison of Quantra Clot Time results to standard coagulation test results (aPTT) Post-bypass, defined as 10 to 20 minutes after protamine administration Coagulation function assessed by Quantra and standard coagulation tests
Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results Post-bypass, 10 to 20 minutes after protamine Coagulation function assessed by Quantra and standard coagulation tests
Comparison of Quantra Clot Stiffness results to TEG MA results Post-bypass, defined as 10 to 20 minutes after protamine administration Coagulation function assessed by Quantra and TEG 5000
Comparison of Quantra Clot Time results to TEG R results Post-bypass, defined as 10 to 20 minutes after protamine administration Coagulation function assessed by Quantra and TEG 5000
Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count Post-bypass, defined as 10 to 20 minutes after protamine administration Coagulation function assessed by Quantra and standard coagulation tests
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States