Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge

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 Surgical Cartridge in patients undergoing major surgical procedures specifically, major cardiac and vascular procedures and major orthopedic surgery (primarily complex spine surgeries).

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 Surgical 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 multi-center, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using the ROTEM Delta.

Official Title
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Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge in Adult Patients Undergoing Major Surgical Procedures

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 either 1) cardiac or vascular surgery utilizing cardiopulmonary bypass (CPB) or 2) orthopedic surgery including major deformity correction spine surgery Subject has a cardiac assist device and is hospitalized for any procedure Subject underwent cardiac, vascular or orthopedic surgery and presents with acute bleeding or suspected hypercoagulability in a post-surgical unit Subject is undergoing emergency cardiac, vascular or orthopedic surgery 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 younger than 18 years Subject is incarcerated at the time of the study Subject is pregnant Subject is currently enrolled in a study that might confound the result of the proposed study Subject is affected by a condition that, in the opinion of the surgical 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 |
| --- | --- |
| Surgical patients<br>Patients undergoing elective cardiac or vascular surgery involving bypass, or major spine surgery, or surgical patients presenting with acute bleeding in a post-surgical unit. | 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 Surgical Cartridge;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Quantra Clot Time and Clot Stiffness results to standard coagulation test results | Coagulation function assessed by Quantra and standard coagulation tests | Baseline, during surgery, and up to 24 hours post-surgery | 
| Comparison of Quantra Clot Time and Clot Stiffness results to comparable ROTEM Delta results | Coagulation function assessed by Quantra and ROTEM Delta | Baseline, during surgery, and up to 24 hours post-surgery | 

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