HemoSonics - UTMB Cardiac Surgery Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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HemoSonics - UTMB Cardiac Surgery Study

Conditions
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Blood Loss, Surgical

Intervention / Treatment
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* Diagnostic Test: Quantra System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac Surgery Patients<br>Patients undergoing cardiopulmonary bypass surgery, including placement of a ventricular access device. | Diagnostic Test: Quantra System<br>* Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.<br>* Other names: Quantra QPlus Cartridge;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Quantra Clot Time results to TEG R results | Coagulation function assessed by Quantra and TEG 5000 | 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 | 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 | During bypass | 
| Comparison of Quantra Clot Stiffness results to TEG MA results | Coagulation function assessed by Quantra and TEG 5000 | During bypass | 
| Comparison of Quantra Clot Time results to TEG R results | Coagulation function assessed by Quantra and TEG 5000 | 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 | 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 | Baseline, defined as after induction of anesthesia but before surgical incision | 
| Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results | Coagulation function assessed by Quantra and standard coagulation tests | 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 | 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 | During bypass | 
| Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results | Coagulation function assessed by Quantra and standard coagulation tests | During bypass | 
| Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count | Coagulation function assessed by Quantra and standard coagulation tests | During bypass | 
| Comparison of Quantra Clot Time results to standard coagulation test results (aPTT) | Coagulation function assessed by Quantra and standard coagulation tests | 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 | 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 | Post-bypass, defined as 10 to 20 minutes after protamine administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viscoelastic testing, Coagulation, Quantra, Hemostasis