Exploratory Assessment of the Quantra® System in Adult ECMO Patients

Study Overview
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Brief Summary
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This is a prospective, observational exploratory study of the performance of the Quantra System in adult patients that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure.

Detailed Description
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Patients 18 years or older that are undergoing an arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure will be enrolled in this prospective, observational exploratory study. From each enrolled subject, blood samples will be collected at multiple time points for analysis on the Quantra QPlus or QStat Cartridge in parallel with other assessments performed as standard of care.

Official Title
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Exploratory Assessment of the Quantra® System With the QPlus® and QStat® Cartridges in Adult ECMO Patients

Conditions
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Blood Loss, Thrombosis, Extracorporeal Circulation; Complications

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 to undergo either VA or VV ECMO procedure or has been placed on VA or VV ECMO within 24 hours. Subject or subject's legally authorized representative (LAR) is willing to provide informed consent, either prospectively or by deferred consent. Exclusion Criteria: Subject is younger than 18 years of age. Subject is pregnant. Subject is incarcerated at the time of the study. Subject, or subject's legally authorized representative is unable or unwilling to provide informed consent. Subject is affected by a condition that, in the opinion of the treatment 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 |
| --- | --- |
| ECMO Patients<br>Patients undergoing an ECMO procedure | Diagnostic Test: Quantra System<br>* Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.<br>|

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 standard coagulation test results. | Coagulation function assessed by Quantra and standard-of-care coagulation tests | At the start of ECMO (considered the Baseline timepoint) | 
| Comparison of Quantra Clot Stiffness results to standard coagulation test results. | Coagulation function assessed by Quantra and standard-of-care coagulation tests | At the start of ECMO (considered the Baseline timepoint) | 
| Comparison of Quantra Clot Time results to standard coagulation test results. | Coagulation function assessed by Quantra and standard-of-care coagulation tests | 6 hours after the previous measurment | 
| Comparison of Quantra Clot Stiffness results to standard coagulation test results. | Coagulation function assessed by Quantra and standard-of-care coagulation tests | 6 hours after the previous measurment | 

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