Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis Assays

Study Overview
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Brief Summary
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This study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests in cardiac surgery patients. In addition the association of Quantra-derived parameters with select platelet function tests will be investigated.

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 (previously called the Surgical Cartridge), was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge provides six parameters that depict the functional status of a patient's coagulation system. This single site, prospective observational study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests (PT, aPTT, fibrinogen, platelet count) in cardiac surgery patients. As an additional exploratory study, the association of Quantra-derived parameters with select platelet function tests will be investigated.

Official Title
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Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis Assays

Conditions
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Coagulation Disorder

Intervention / Treatment
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* Diagnostic Test: Quantra System with the QPlus Cartridge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is >18 years Subject is undergoing elective cardiac surgery with cardiopulmonary bypass Subject is willing to participate and has signed a consent form Exclusion Criteria: Subject is younger than 18 years Subject has known congenital coagulopathy Subject is unable 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cardiac surgery patients<br>Patients undergoing elective cardiac surgery requiring cardiopulmonary bypass. | Diagnostic Test: Quantra System with the QPlus Cartridge<br>* Point-of-care viscoelastic testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta results | Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta | Baseline (before surgery) | 
| Comparison of QPlus Clot Time and Clot Stiffness results to comparable ROTEM delta | Coagulation function assessed by Quantra QPlus Cartridge and ROTEM delta | After cardiac bypass (10 minutes after administration of protamine) | 
| Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results | Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests | Baseline (before surgery) | 
| Comparison of QPlus Clot Time and Clot Stiffness results to standard coagulation test results | Coagulation function assessed by Quantra QPlus Cartridge and standard coagulation tests | After cardiac bypass (10 minutes after administration of protamine) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest | Platelet function assessed by Quantra QPlus Cartridge and MEA | Baseline (before surgery) | 
| Comparison of QPlus Clot Stiffness results to platelet function tests with multiple electrode aggregometry (MEA): ADPtest and TRAPtest | Platelet function assessed by Quantra QPlus Cartridge and MEA | After cardiac bypass (10 minutes after administration of protamine) |