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

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ClinicalTrials.gov Identifier: NCT03934983
Recruitment Status : Enrolling by invitation
First Posted : May 2, 2019
Last Update Posted : May 2, 2019
Sponsor:
Information provided by (Responsible Party):
HemoSonics LLC

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

Condition or disease Intervention/treatment
Blood Loss Massive Trauma Diagnostic Test: Quantra System

Detailed Description:

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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : June 28, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Trauma patients
Subject experiencing major trauma such that viscoelastic testing is performed as standard of care to assess coagulopathy.
Diagnostic Test: Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Other Name: Quantra QStat Cartridge




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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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
Potential study participants will be adult (>18 years) trauma patients where visicoelastic testing is performed as standard of care to assess coagulopathy.
Criteria

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.

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): NCT03934983


Locations
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United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
HemoSonics LLC

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Responsible Party: HemoSonics LLC
ClinicalTrials.gov Identifier: NCT03934983     History of Changes
Other Study ID Numbers: HEMCS-021
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: May 2, 2019
Last Verified: April 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: Yes
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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Wounds and Injuries