Quantra QPlus Sample Type Comparison

Study Overview
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Brief Summary
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This is a single center prospective observational study to compare QPlus parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing cardiac surgery.

Detailed Description
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In this single center prospective observational study, 40 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 120 matched samples for analysis on the Quantra System with the QPlus Cartridge.

Official Title
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Impact of Sample Type and Assay Time on the Performance of the Quantra QPlus System

Conditions
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Coagulation Defect; Bleeding

Intervention / Treatment
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* Diagnostic Test: Quantra QPlus System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device Subject is ≥18 years Subject or subject's legally authorized representative is willing to participate and he/she has signed a consent formr. Exclusion Criteria: Subject is younger than 18 years Subject is pregnant Subject is incarcerated at the time of the study Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks Subject, or subject's legally aurthorized representative is able to provide written informed consent

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Quantra QPlus System|Whole blood coagulation testing system|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of QPlus Clot time (CT) in arterial and venous samples | Coagulation function assessed in two sample types | During cardiac surgery | 
| Comparison of QPlus Clot time with Heparinase (CTH) in arterial and venous samples | Coagulation function assessed in two sample types | During cardiac surgery | 
| Comparison of Clot stiffness (CS) determined with Quantra QPlus Cartridge in arterial and venous samples | Measure of the overall shear modulus or strength/quality of the clot determined using SEER sonorheometry assessed in two sample types | During cardiac surgery | 
| Comparison of QPlus Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples | Measure of the shear modulus or strength/quality of the clot contributed by platelets determined using SEER sonorheometry assessed in two sample types | During cardiac surgery | 
| Comparison of QPlus Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples | Measure of the shear modulus or strength/quality of the clot contributed by fibrinogen determined using SEER sonorheometry assessed in two sample types | During cardiac surgery | 

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