Exploratory Assessment of the Quantra® System in Adult ECMO Patients

Sponsor

HemoSonics LLC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05426564

Collaborator

University of Minnesota (Other)

Enrollment

Location

5.7

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Blood Loss Thrombosis Extracorporeal Circulation; Complications	Diagnostic Test: Quantra System

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Aug 27, 2022

Anticipated Primary Completion Date :

Jan 31, 2023

Anticipated Study Completion Date :

Feb 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
ECMO Patients Patients undergoing an ECMO procedure	Diagnostic Test: Quantra System Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Arm

Intervention/Treatment

ECMO Patients

Patients undergoing an ECMO procedure

Diagnostic Test: Quantra System

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

Outcome Measures

Primary Outcome Measures

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
Comparison of Quantra Clot Time results to standard coagulation test results. [6 hours after the previous measurment]
Coagulation function assessed by Quantra and standard-of-care coagulation tests
Comparison of Quantra Clot Stiffness results to standard coagulation test results. [6 hours after the previous measurment]
Coagulation function assessed by Quantra and standard-of-care coagulation tests

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.