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OpenTrials
Completed

NCT Number: NCT05426564

Exploratory Assessment of the Quantra® System 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.

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Key information

Conditions

Blood Loss Cardiovascular Diseases Embolism and Thrombosis Extracorporeal Circulation; Complications Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California Irvine

Irvine, California, 92697, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quantra System

Diagnostic Test

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Collaborators

  • University of California, Irvine

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 22, 2022
Registry last updated
Jun 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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