Quantra QStat in Trauma and Liver Transplant

Study Overview
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Brief Summary
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This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.

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 QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies, including fibrinolytic defects. These patients include the trauma and liver transplant populations. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system. This multi-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to conventional viscoelastic testing methods in blood samples obtained from trauma patients and patients undergoing liver transplant.

Official Title
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Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma and Liver Transplantation

Conditions
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Hemorrhage, Trauma, Liver Transplant

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 a trauma patient experiencing traumatic injuries requiring a full trauma team response OR Subject is a patient undergoing liver transplant surgery. Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent, OR Institutional Review Board (IRB)/Ethics Committee (EC) has waived the requirement to obtain informed consent. Exclusion Criteria: Subject is younger than 18 years of age Subject is pregnant. Subject is incarcerated at the time of the study. Subject is currently enrolled in a distinct 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

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Trauma patients<br>Trauma patients experiencing traumatic injuries requiring a full trauma team response. | 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;|
| Liver transplant patients<br>Patients undergoing liver transplant surgery. | 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 (CT) to ROTEM Delta INTEM CT results | Coagulation function assessed by Quantra and ROTEM Delta | Upon arrival of trauma subject to the emergency department | 
| Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results | Coagulation function assessed by Quantra and ROTEM Delta | Baseline, immediately before the start of liver transplant surgery | 
| Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results | Coagulation function assessed by Quantra and ROTEM Delta | During anhepatic phase of liver transplant surgery | 
| Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results | Coagulation function assessed by Quantra and ROTEM Delta | During post-reperfusion phase of liver transplant surgery | 
| Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | Upon arrival of trauma subject to the emergency department | 
| Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | Baseline, immediately before the start of liver transplant surgery | 
| Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | During anhepatic phase of liver transplant surgery | 
| Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | During post-reperfusion phase of liver transplant surgery | 
| Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | Upon arrival of trauma subject to the emergency department | 
| Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | Baseline, immediately before the start of liver transplant surgery | 
| Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | During anhepatic phase of liver transplant surgery | 
| Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results | Coagulation function assessed by Quantra and ROTEM Delta | During post-reperfusion phase of liver transplant surgery | 
| Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results | Coagulation function assessed by Quantra and ROTEM Delta | Upon arrival of trauma subject to the emergency department | 
| Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results | Coagulation function assessed by Quantra and ROTEM Delta | Baseline, immediately before the start of liver transplant surgery | 
| Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results | Coagulation function assessed by Quantra and ROTEM Delta | During anhepatic phase of liver transplant surgery | 
| Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results | Coagulation function assessed by Quantra and ROTEM Delta | During post-reperfusion phase of liver transplant surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Viscoelastic testing, Coagulation, Trauma, Liver Transplant, Quantra, QStat