Exploratory Assessment of the Quantra® System in Adult ECMO Patients

HemoSonics LLC10 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Blood Loss Thrombosis Extracorporeal Circulation; Complications

Interventions

Quantra SystemDIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of California Irvine

Irvine, California, United States

Outcomes

Primary Outcomes

Comparison of Quantra Clot Time results to standard coagulation test results.

Coagulation function assessed by Quantra and standard-of-care coagulation tests

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 6 hours after the previous measurment

Data from ClinicalTrials.gov

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