Blood Loss, Extracorporeal Circulation; Complications, Thrombosis
Conditions
Keywords
Quantra, ECMO, QPlus, Viscoelastic testing, Coagulation
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTQuantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Sponsors
University of California, Irvine
HemoSonics LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Quantra Clot Time results to standard coagulation test results. | At the start of ECMO (considered the Baseline timepoint) | Coagulation function assessed by Quantra and standard-of-care coagulation tests |
| Comparison of Quantra Clot Stiffness results to standard coagulation test results. | At the start of ECMO (considered the Baseline timepoint) | Coagulation function assessed by Quantra and standard-of-care coagulation tests |
Countries
United States
Outcome results
None listed