Quantra QPlus Sample Type Comparison

April 28, 2023 updated by: HemoSonics LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

50

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
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Wexner Medical Center

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult males and females undergoing cardiac surgery

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of QPlus Clot time (CT) in arterial and venous samples
Time Frame: During cardiac surgery
Coagulation function assessed in two sample types
During cardiac surgery
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
During cardiac surgery
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
During cardiac surgery
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
During cardiac surgery
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
During cardiac surgery

Collaborators and Investigators

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

Sponsor

HemoSonics LLC

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)

November 4, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

November 2, 2022

Study Registration Dates

First Submitted

January 13, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 22, 2022

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMCS-042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

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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