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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931031
Recruitment Status : Completed
First Posted : April 29, 2019
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
HemoSonics LLC

Brief Summary:
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.

Condition or disease Intervention/treatment
Blood Loss, Surgical Diagnostic Test: Quantra System

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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery
Actual Study Start Date : March 21, 2019
Actual Primary Completion Date : April 7, 2020
Actual Study Completion Date : June 27, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

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 Name: Quantra QPlus Cartridge




Primary Outcome Measures :
  1. Comparison of Quantra Clot Time test results to TEG test results. [ Time Frame: Prior to surgery (Baseline) ]
    Coagulation function assessed by Quantra and TEG.

  2. Comparison of Quantra Clot Stiffness test results to TEG test results. [ Time Frame: Prior to surgery (Baseline) ]
    Coagulation function assessed by Quantra and TEG.

  3. 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.

  4. 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.

  5. 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

  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931031


Locations
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United States, Alabama
Huntsville Hospital
Huntsville, Alabama, United States, 35801
Sponsors and Collaborators
HemoSonics LLC
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Responsible Party: HemoSonics LLC
ClinicalTrials.gov Identifier: NCT03931031    
Other Study ID Numbers: HEMCS-017
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by HemoSonics LLC:
Viscoelastic testing
Coagulation
Quantra
Hemostasis
Additional relevant MeSH terms:
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Blood Loss, Surgical
Hemorrhage
Pathologic Processes
Intraoperative Complications