QStat in Liver Transplant

Study Overview
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Brief Summary
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This study will assess the clinical performance of the Quantra System with the QStat Cartridge in the liver transplant population.

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 propoerties of a whole blood sample during coagulation. The Quantra QStat Cartridge was developed to monitor hemostasis in the trauma and liver transplant populations which may experience a range of coagulopathies of various etiologies including fibrinolytic defects. This single-center, prospective, observational stuey will evaluate the performance of the Quantra System with the QStat Cartridge as compared to corresponding measures determined using the TEG 5000.

Official Title
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Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Liver Transplant

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 of age Subject is undergoing deceased donor liver transplant and is a candidate for a TEG test to be performed to access coagulopathy during surgery. Subject is willing to participate, and is willing to consent (either prospectively or by deferred consent) Exclusion Criteria: Subject is younger than 18 years of age Subject is known to have received antifibrinolytic therapy immediately prior to the start of liver transplantation surgery. Subject is unable to provide written informed consent (either prior to performing any study related procedures or by deferred consent) 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 |
| --- | --- |
| Liver transplant patients<br>Adult patients undergoing deceased donor liver transplantation. | 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 QStat Cartridge;|

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, 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, after induction of anesthesia, before surgical incision | 
| Comparison of Quantra Clot Lysis results to TEG LI30 results | Coagulation function assessed by Quantra and TEG 5000 | Baseline, after induction of anesthesia, before surgical incision | 
| Comparison of Quantra Clot 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 Lysis results to TEG LI30 results | Coagulation function assessed by Quantra and TEG 5000 | During 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