Exploratory Assessment of the Quantra® System in Adult ECMO Patients

June 14, 2023 updated by: HemoSonics LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • University of California Irvine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing arterio-venous (AV), veno-venous (VV) ECMO or extra-corporeal life support (ECLS) procedure. Both COVID-19 and non-COVID-19 related ECMO patients will be enrolled

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HemoSonics LLC

Collaborators

University of California, Irvine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2022

Primary Completion (Actual)

May 17, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 21, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMCS-041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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