Exploratory Assessment of the Quantra® System in Adult ECMO Patients

Completed

• Conditions: Thrombosis; Extracorporeal Circulation; Complications; Blood Loss
• Interventions: Diagnostic Test: Quantra System

• Registration Number: NCT05426564
• Lead Sponsor: HemoSonics LLC

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.

Study Timeline

• Study First Submitted: 2022-06-07
• Study First Submitted QC: 2022-06-21
• Study First Posted: 2022-06-22
• Study Start: 2022-09-27
• Primary Completion: 2023-05-17
• Status Verified: 2023-06
• Study Completion: 2023-06-01
• Last Update Submitted: 2023-06-14
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ECMO Patients	Quantra System	Patients undergoing an ECMO procedure

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of California Irvine; 🇺🇸 Irvine, California, United States