Exploratory Assessment of the Quantra® System in Adult ECMO Patients

Thrombosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05426564
• Other study ID #: HEMCS-041
• Status: Completed
• Start date: September 27, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 1, 2023
• Est. primary completion date: May 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss
• Extracorporeal Circulation; Complications
• Thrombosis

Intervention

Diagnostic Test:
• Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Locations

Country	Name	City	State
United States	University of California Irvine	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
HemoSonics LLC	University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Quantra Clot Time results to standard coagulation test results.	Coagulation function assessed by Quantra and standard-of-care coagulation tests	At the start of ECMO (considered the Baseline timepoint)
Primary	Comparison of Quantra Clot Stiffness results to standard coagulation test results.	Coagulation function assessed by Quantra and standard-of-care coagulation tests	At the start of ECMO (considered the Baseline timepoint)
Primary	Comparison of Quantra Clot Time results to standard coagulation test results.	Coagulation function assessed by Quantra and standard-of-care coagulation tests	6 hours after the previous measurment
Primary	Comparison of Quantra Clot Stiffness results to standard coagulation test results.	Coagulation function assessed by Quantra and standard-of-care coagulation tests	6 hours after the previous measurment