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Completed

NCT Number: NCT03934983

Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma

This pilot study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients.

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Key information

Conditions

Blood Loss Massive Cardiovascular Diseases Embolism and Thrombosis Thrombosis Trauma Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, 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 QStat Cartridge was developed to monitor hemostasis in patients that may experience a range of coagulopathies of various etiologies including fibrinolytic defects. This includes the trauma patient population. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding five parameters that depict the functional status of a patient's coagulation system.

This single-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to standard coagulation tests and comparable measures using conventional viscoelastic testing methods.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is ≥ 18 years of age
  • Subject is a trauma patient and is a candidate for a ROTEM test to be performed to access coagulopathy
  • Subject must be experiencing major trauma (preferably requiring the highest level of team activation) with active bleeding or deemed at high risk of significant bleeding according to mechanism of injury.
  • Subject is willing to participate, and is willing to consent (either prospectively or by deferred consent)

Exclusion criteria

  • Subject is younger than 18 years of age
  • Subject weighs less than 110 pounds
  • Subject is known to have received antifibrinolytic therapy immediately prior to presentation to trauma unit
  • Subject is unable to provide written informed consent (either prior to performing any study related procedures or by deferred consent)
  • 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 QStat Cartridge

Primary outcomes

  1. Comparison of the Quantra Clot Time results to standard coagulation test results

    Time frame: Upon arrival to emergency department

    Coagulation function assessed by Quantra and standard coagulation tests

  2. Comparison of the Quantra Clot Stiffness results to standard coagulation test results

    Time frame: Upon arrival to emergency department

    Coagulation function assessed by Quantra and standard coagulation tests

  3. Comparison of the Quantra Clot Time results to ROTEM Delta results

    Time frame: Upon arrival to emergency department

    Coagulation function assessed by Quantra and ROTEM delta

  4. Comparison of the Quantra Clot Stiffness results to ROTEM Delta results

    Time frame: Upon arrival to emergency department

    Coagulation function assessed by Quantra and ROTEM delta

  5. Comparison of the Quantra Fibrinolysis results to ROTEM Delta results

    Time frame: Upon arrival to emergency department

    Coagulation function assessed by Quantra and ROTEM delta

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 2, 2019
Registry last updated
Feb 13, 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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