Evaluation of the Quantra System in a Surgical Oncological Population

Study Overview
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Brief Summary
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This study will monitor coagulation parameters during the perioperative course of cancer surgical procedures using the Quantra System with the QPlus Cartridge.

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 iin parallel yielding six parameters that depict the functional status of a patient's coagulation system. The oncologic surgical population presents unique challenges to providers who must distinguish between a cancer patient's increased tendency toward both thrombosis and hemorrhage. This single site prospective observational study in oncologic patients will give an insight into the coagulation status of critically ill cancer patients.

Official Title
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Evaluation of the Quantra System in a Surgical Oncological Population

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 diagnosed with cancer and is scheduled for surgical resection Subject is willing to participate, and he/she or a Legally Authorized Representative (LAR) has signed a consent form Surgical procedure to be performed has an anticipated blood loss (>500mL) based on historical data Exclusion Criteria: Subject is younger than 18 years Subject or a subject's LAR is unable to provide written informed consent Subject is undergoing an emergent procedure. Subject is pregnant, has active liver disease, or severe renal dysfunction (creatinine clearance (CrCL)<30 mL/min) Subject has an extremely low platelet count (<40,000/uL) 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 |
| --- | --- |
| Cancer surgery patients<br>Adult subjects (18 years or older) undergoing an oncologic surgical procedure. | 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 System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Quantra Clot Time results to TEG R results | Coagulation function assessed by Quantra and TEG 5000 | Baseline, defined as after induction of anesthesia, before surgical incision | 
| Comparison of Quantra Clot Stiffness results to TEG MA results | Coagulation function assessed by Quantra and TEG 5000 | Baseline, defined as after induction of anesthesia, before surgical incision | 
| Comparison of Quantra Time results to TEG R results | Coagulation function assessed by Quantra and TEG 5000 | During surgery | 
| Comparison of Quantra Clot Stiffness results to TEG MA results | Coagulation function assessed by Quantra and TEG 5000 | During surgery | 
| Comparison of Quantra Clot Time results to TEG R results | Coagulation function assessed by Quantra and TEG 5000 | Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery | 
| Comparison of Quantra Clot Stiffness results to TEG MA results | Coagulation function assessed by Quantra and TEG 5000 | Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery | 

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