Hemosonics- VCU Cardiac Surgery Clinical Study

Study Overview
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Brief Summary
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This study compares the results of current standard coagulation measurement devices to the Quantra System, a new device, using small amount of extra blood obtained during routine blood draws in cardiac surgery patients.

Detailed Description
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HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia. Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients. A clinical study will be conducted to evaluate the analytical performance as well as provide a preliminary evaluation of the performance comparability of the HemoSonics' device as compared to existing coagulation monitoring technology in heart surgery. This study will be performed at HemoSonics and the Virginia Commonwealth University Medical Center and will involve patients undergoing cardiac surgery requiring bypass.

Official Title
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Hemosonics- VCU Cardiac Surgery Clinical Study Protocol

Conditions
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Cardiopulmonary Bypass

Intervention / Treatment
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* Device: Coagulation function


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is scheduled for cardiac surgery involving bypass circuit Subject is older than 18 years Subject is willing to participate and he/she has signed a consent form Exclusion Criteria: Subject is unable to provide written informed consent Subject is incarcerated at the time of the study Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks Patients on emergency cases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 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>Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry | Device: Coagulation function<br>* Coagulation function assessment tools TEG (standard of practice) vs SEER Quantra (novel coagulation function device)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clot Time | Coagulation Function assessed at 4 time points [baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU] over the course of cardiac surgery until patient ICU transfer | 1 day | 
| Clot Stiffness | Coagulation Function assessed at 4 time points (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU) over the course of cardiac surgery and bypass until patient ICU transfer | 1 day |