Exploratory Assessment of the Quantra® System in Adult ECMO Patients

HemoSonics

Status: Completed

Conditions: Thrombosis; Extracorporeal Circulation; Complications; Blood Loss

Treatments: Diagnostic Test: Quantra System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05426564

HEMCS-041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

10 participants in 1 patient group

ECMO Patients

Description:

Patients undergoing an ECMO procedure

Treatment:

Diagnostic Test: Quantra System