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HemoSonics - UTMB Cardiac Surgery Study

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ClinicalTrials.gov Identifier: NCT03988465
Recruitment Status : Not yet recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
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 Quantra QPlus Cartridge in patients undergoing cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.

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, and 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-center, prospective, observational study will evaluate the performance of the Quantra System as compared to and comparable measures determined using the TEG 5000.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HemoSonics - UTMB Cardiac Surgery Study
Estimated Study Start Date : June 19, 2019
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : November 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
Cardiac Surgery Patients
Patients undergoing cardiopulmonary bypass surgery, including placement of a ventricular access device.
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 results to TEG R results [ Time Frame: Baseline, defined as after induction of anesthesia but before surgical incision ]
    Coagulation function assessed by Quantra and TEG 5000

  2. Comparison of Quantra Clot Stiffness results to TEG MA results [ Time Frame: Baseline, defined as after induction of anesthesia but before surgical incision ]
    Coagulation function assessed by Quantra and TEG 5000

  3. Comparison of Quantra Clot Time results to TEG R results [ Time Frame: During bypass ]
    Coagulation function assessed by Quantra and TEG 5000

  4. Comparison of Quantra Clot Stiffness results to TEG MA results [ Time Frame: During bypass ]
    Coagulation function assessed by Quantra and TEG 5000

  5. Comparison of Quantra Clot Time results to TEG R results [ Time Frame: Post-bypass, defined as 10 to 20 minutes after protamine administration ]
    Coagulation function assessed by Quantra and TEG 5000

  6. Comparison of Quantra Clot Stiffness results to TEG MA results [ Time Frame: Post-bypass, defined as 10 to 20 minutes after protamine administration ]
    Coagulation function assessed by Quantra and TEG 5000

  7. Comparison of Quantra Clot Time results to standard coagulation test results (aPTT) [ Time Frame: Baseline, defined as after induction of anesthesia but before surgical incision ]
    Coagulation function assessed by Quantra and standard coagulation tests

  8. Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results [ Time Frame: Baseline, defined as after induction of anesthesia but before surgical incision ]
    Coagulation function assessed by Quantra and standard coagulation tests

  9. Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count [ Time Frame: Baseline, defined as after induction of anesthesia but before surgical incision ]
    Coagulation function assessed by Quantra and standard coagulation tests

  10. Comparison of Quantra Clot Time results to standard coagulation test results (aPTT) [ Time Frame: During bypass ]
    Coagulation function assessed by Quantra and standard coagulation tests

  11. Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results [ Time Frame: During bypass ]
    Coagulation function assessed by Quantra and standard coagulation tests

  12. Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count [ Time Frame: During bypass ]
    Coagulation function assessed by Quantra and standard coagulation tests

  13. Comparison of Quantra Clot Time results to standard coagulation test results (aPTT) [ Time Frame: Post-bypass, defined as 10 to 20 minutes after protamine administration ]
    Coagulation function assessed by Quantra and standard coagulation tests

  14. Comparison of Quantra Clot Stiffness results to laboratory fibrinogen results [ Time Frame: Post-bypass, 10 to 20 minutes after protamine ]
    Coagulation function assessed by Quantra and standard coagulation tests

  15. Comparison of Quantra Clot Stiffness results to laboratory-determined platelet count [ Time Frame: Post-bypass, defined as 10 to 20 minutes after protamine administration ]
    Coagulation function assessed by Quantra and standard coagulation tests



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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
The study population includes subjects 18 years or older undergoing cardiac surgery utilizing cardiopulmonary bypass, including placement of a ventricular access device.
Criteria

Inclusion Criteria:

  • Subject is ≥ 18 years
  • Subject is scheduled for cardiac surgery utilizing cardiopulmonary bypass, including the placement of a ventricular access device.
  • Subject is willing to participate, and he/she has signed a consent form.

Exclusion Criteria:

  • Subject is younger than 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): NCT03988465


Contacts
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Contact: Deborah Winegar, PhD 919-244-6990 dwinegar@hemosonics.com

Locations
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United States, Texas
University of Texas Medical Branch Not yet recruiting
Galveston, Texas, United States, 77555
Contact: Sean Yates, MD    409-772-3317    sgyates@utmb.edu   
Sponsors and Collaborators
HemoSonics LLC

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Responsible Party: HemoSonics LLC
ClinicalTrials.gov Identifier: NCT03988465     History of Changes
Other Study ID Numbers: HEMCS-024
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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