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OpenTrials
Completed

NCT Number: NCT05290675

Quantra QPlus Sample Type Comparison

This is a single center prospective observational study to compare QPlus parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing cardiac surgery.

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Key information

Conditions

Coagulation Defect; Bleeding Cardiovascular Diseases Embolism and Thrombosis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders 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

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

About this study

In this single center prospective observational study, 40 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 120 matched samples for analysis on the Quantra System with the QPlus Cartridge.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device
  • Subject is ≥18 years
  • Subject or subject's legally authorized representative is willing to participate and he/she has signed a consent formr.

Exclusion criteria

  • Subject is younger than 18 years
  • Subject is pregnant
  • Subject is incarcerated at the time of the study
  • Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks
  • Subject, or subject's legally aurthorized representative is able to provide written informed consent

Treatment and study plan

Quantra QPlus System

Diagnostic Test

Whole blood coagulation testing system

Primary outcomes

  1. Comparison of QPlus Clot time (CT) in arterial and venous samples

    Time frame: During cardiac surgery

    Coagulation function assessed in two sample types

  2. Comparison of QPlus Clot time with Heparinase (CTH) in arterial and venous samples

    Time frame: During cardiac surgery

    Coagulation function assessed in two sample types

  3. Comparison of Clot stiffness (CS) determined with Quantra QPlus Cartridge in arterial and venous samples

    Time frame: During cardiac surgery

    Measure of the overall shear modulus or strength/quality of the clot determined using SEER sonorheometry assessed in two sample types

  4. Comparison of QPlus Platelet Contribution to Clot stiffness (PCS) in arterial and venous samples

    Time frame: During cardiac surgery

    Measure of the shear modulus or strength/quality of the clot contributed by platelets determined using SEER sonorheometry assessed in two sample types

  5. Comparison of QPlus Fibrinogen Contribution to Clot stiffness (FCS) in arterial and venous samples

    Time frame: During cardiac surgery

    Measure of the shear modulus or strength/quality of the clot contributed by fibrinogen determined using SEER sonorheometry assessed in two sample types

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Official study title

Impact of Sample Type and Assay Time on the Performance of the Quantra QPlus System

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2022
Registry last updated
May 1, 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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