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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/23/2021.

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

Clinicaltrials.gov identifier NCT03934983

Recruitment Status Completed

First Posted May 2, 2019

Last update posted February 13, 2020

Study Description

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:Blood Loss Massive
    Trauma
  • Intervention/Treatment: Diagnostic Test: Quantra System
  • Phase: N/A
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.

Study Design
  • Study Type: Observational
  • Actual 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 2019
  • Actual Primary Completion Date: January 2020
  • Actual Study Completion Date: January 2020
Groups and Cohorts
Groups/Cohorts 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.
Outcome Measures
  • 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
Eligibility Criteria
  • 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.

Contacts and Locations
Contacts
Locations

United States, Texas
University of Texas Southwestern Medical Center
Dallas

Sponsors and Collaborators

HemoSonics LLC

More Information
  • 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: February 13, 2020
  • Last Verified: February 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by HemoSonics LLC: Viscoelastic testing
    Coagulation
    Quantra
    Hemostasis
  • Additional relevant MeSH terms: Wounds and Injuries