Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery

June 30, 2020 updated by: HemoSonics LLC
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra QPlus Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system.

This single-site, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using TEG in patients taking antiplatelet medication that are scheduled to undergo cardiac surgery.

Study Type

Observational

Enrollment (Actual)

40

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
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Huntsville Hospital

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Potential study participants will be adult (≥ 18 years) subjects who are taking antiplatelet medication and who are scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device.

Description

Inclusion Criteria:

  • Subject is scheduled for elective cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular assist device
  • Subject was identified as taking antiplatelet medication, specifically a P2Y12 inhibitor such that a TEG Platelet Mapping test is prescribed prior to surgery to assess possible platelet inhibition
  • Subject is ≥ 18 years
  • Subject is willing to participate and he/she has signed a consent form

Exclusion Criteria:

  • Subject is younger that 18 years
  • Subject is unable to provide written informed consent
  • Subject is incarcerated at the time of the study
  • Subject is pregnant
  • Subject is currently enrolled in a distinct study that might confound the results of the proposed study
  • Subject is affected by a condition that, in the opinion of the clinical 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
Cardiac Surgery Patients
Patients taking antiplatelet medication who are scheduled for elective cardiac surgery.
Diagnostic test: Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care
Other Names:
  • Quantra QPlus Cartridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Quantra Clot Time test results to TEG test results.
Time Frame: Prior to surgery (Baseline)
Coagulation function assessed by Quantra and TEG.
Prior to surgery (Baseline)
Comparison of Quantra Clot Stiffness test results to TEG test results.
Time Frame: Prior to surgery (Baseline)
Coagulation function assessed by Quantra and TEG.
Prior to surgery (Baseline)
Comparison of Quantra Clot Time and Clot Stiffness test results to TEG test results.
Time Frame: Post-bypass (10 to 20 minutes after protamine administration).
Coagulation function assessed by Quantra and TEG.
Post-bypass (10 to 20 minutes after protamine administration).
Comparison of Quantra Clot Time test results to TEG test results.
Time Frame: Post-bypass (10 to 20 minutes after protamine administration).
Coagulation function assessed by Quantra and TEG.
Post-bypass (10 to 20 minutes after protamine administration).
Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen
Time Frame: Prior to surgery (Baseline)
Coagulation function assessed by Quantra and laboratory fibrinogen testing
Prior to surgery (Baseline)
Comparison of Quantra Fibrinogen Contribution to Clot Stiffness test results to laboratory fibrinogen
Time Frame: Post-bypass (10 to 20 minutes after protamine administration).
Coagulation function assessed by Quantra and laboratory fibrinogen testing
Post-bypass (10 to 20 minutes after protamine administration).
Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count
Time Frame: Post-bypass (10 to 20 minutes after protamine administration).
Coagulation function assessed by Quantra and laboratory fibrinogen testing
Post-bypass (10 to 20 minutes after protamine administration).
Comparison of Quantra Platelet Contribution to Clot Stiffness test results to laboratory platelet count
Time Frame: Prior to surgery (Baseline)
Coagulation function assessed by Quantra and platelet count
Prior to surgery (Baseline)

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)

March 21, 2019

Primary Completion (Actual)

April 7, 2020

Study Completion (Actual)

June 27, 2020

Study Registration Dates

First Submitted

April 20, 2019

First Submitted That Met QC Criteria

April 25, 2019

First Posted (Actual)

April 29, 2019

Study Record Updates

Last Update Posted (Actual)

July 1, 2020

Last Update Submitted That Met QC Criteria

June 30, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEMCS-017

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.

No

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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