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Exploratory Assessment of the Quantra® System in Adult ECMO Patients | Clinical Trials | Clareo Health

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Exploratory Assessment of the Quantra® System in Adult ECMO Patients

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

NCT05426564•HemoSonics LLC

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Key Dates

Start Date

September 27, 2022

Primary Completion Date

May 17, 2023

Completion Date

June 1, 2023

Last Updated

June 15, 2023

Enrollment

ACTUAL participants

Conditions

Blood LossThrombosisExtracorporeal Circulation; Complications

Interventions

Quantra System

DIAGNOSTIC_TEST

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 15, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Exploratory Assessment of the Quantra® System in Adult ECMO Patients

Inclusion Criteria

Exclusion Criteria

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