Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery

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 QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.

Detailed Description
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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 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-site, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using TEG in patients taking antiplatelet medication that are scheduled to undergo cardiac surgery.

Official Title
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Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery

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 scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device Subject was identified as taking antiplatelet medication, specifically a P2Y12 inhibitor such that a TEG Platelet Mapping test is prescribed prior to surgery to assess possible platelet inhibition Subject is ≥ 18 years Subject is willing to participate and he/she has signed a consent form Exclusion Criteria: Subject is younger that 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 taking antiplatelet medication who are scheduled for elective cardiac surgery. | 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 test results to TEG test results. | Coagulation function assessed by Quantra and TEG. | Prior to surgery (Baseline) | 
| Comparison of Quantra Clot Stiffness test results to TEG test results. | Coagulation function assessed by Quantra and TEG. | Prior to surgery (Baseline) | 
| Comparison of Quantra Clot Time and Clot Stiffness test results to TEG test results. | Coagulation function assessed by Quantra and TEG. | Post-bypass (10 to 20 minutes after protamine administration). | 
| Comparison of Quantra Clot Time test results to TEG test results. | Coagulation function assessed by Quantra and TEG. | Post-bypass (10 to 20 minutes after protamine administration). | 
| Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen | Coagulation function assessed by Quantra and laboratory fibrinogen testing | Prior to surgery (Baseline) | 
| Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen | Coagulation function assessed by Quantra and laboratory fibrinogen testing | Post-bypass (10 to 20 minutes after protamine administration). | 
| Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count | Coagulation function assessed by Quantra and laboratory fibrinogen testing | Post-bypass (10 to 20 minutes after protamine administration). | 
| Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count | Coagulation function assessed by Quantra and platelet count | Prior to surgery (Baseline) | 

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