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Completed

NCT Number: NCT03931031

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

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.

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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

Huntsville Hospital

Huntsville, Alabama, 35801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

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 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

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 29, 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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