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Completed

NCT Number: NCT04116385

Evaluation of the Quantra System in a Surgical Oncological Population

This study will monitor coagulation parameters during the perioperative course of cancer surgical procedures using the Quantra System with the QPlus Cartridge.

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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 MD Anderson Cancer Center

Houston, Texas, 77030, 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 iin parallel yielding six parameters that depict the functional status of a patient's coagulation system.

The oncologic surgical population presents unique challenges to providers who must distinguish between a cancer patient's increased tendency toward both thrombosis and hemorrhage. This single site prospective observational study in oncologic patients will give an insight into the coagulation status of critically ill cancer patients.

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 diagnosed with cancer and is scheduled for surgical resection
  • Subject is willing to participate, and he/she or a Legally Authorized Representative (LAR) has signed a consent form
  • Surgical procedure to be performed has an anticipated blood loss (>500mL) based on historical data

Exclusion criteria

  • Subject is younger than 18 years
  • Subject or a subject's LAR is unable to provide written informed consent
  • Subject is undergoing an emergent procedure.
  • Subject is pregnant, has active liver disease, or severe renal dysfunction (creatinine clearance (CrCL)<30 mL/min)
  • Subject has an extremely low platelet count (<40,000/uL)
  • 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 System

Primary outcomes

  1. Comparison of Quantra Clot Time results to TEG R results

    Time frame: Baseline, defined as after induction of anesthesia, 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, before surgical incision

    Coagulation function assessed by Quantra and TEG 5000

  3. Comparison of Quantra Time results to TEG R results

    Time frame: During surgery

    Coagulation function assessed by Quantra and TEG 5000

  4. Comparison of Quantra Clot Stiffness results to TEG MA results

    Time frame: During surgery

    Coagulation function assessed by Quantra and TEG 5000

  5. Comparison of Quantra Clot Time results to TEG R results

    Time frame: Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery

    Coagulation function assessed by Quantra and TEG 5000

  6. Comparison of Quantra Clot Stiffness results to TEG MA results

    Time frame: Post-surgery, while patient is in the ICU/PACU, usually within 24 hours of surgery

    Coagulation function assessed by Quantra and TEG 5000

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 4, 2019
Registry last updated
Sep 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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