Exploratory Assessment of the Quantra® System in Adult ECMO Patients

NCT ID: NCT05426564

Last Updated: 2023-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-27

Study Completion Date

2023-06-01

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.

Conditions

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Blood Loss Thrombosis Extracorporeal Circulation; Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ECMO Patients

Patients undergoing an ECMO procedure

Quantra System

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Quantra System

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

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, Irvine

OTHER

Sponsor Role collaborator

HemoSonics LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California Irvine

Irvine, California, United States

Site Status

Countries

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United States

Other Identifiers

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HEMCS-041

Identifier Type: -

Identifier Source: org_study_id

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