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Completed

NCT Number: NCT03988465

HemoSonics - UTMB Cardiac Surgery Study

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.

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Key information

Conditions

Blood Loss, Surgical Cardiovascular Diseases Embolism and Thrombosis Hemorrhage Intraoperative Complications 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

University of Texas Medical Branch

Galveston, Texas, 77555, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Quantra System

Diagnostic Test

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Other names: Quantra QPlus Cartridge

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 17, 2019
Registry last updated
Jul 1, 2020

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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