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.

Study Overview

• Status: Completed
• Conditions: Trauma; Blood Loss Massive
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Quantra QStat Cartridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the Quantra Clot Time results to standard coagulation test results	Coagulation function assessed by Quantra and standard coagulation tests	Upon arrival to emergency department
Comparison of the Quantra Clot Stiffness results to standard coagulation test results	Coagulation function assessed by Quantra and standard coagulation tests	Upon arrival to emergency department
Comparison of the Quantra Clot Time results to ROTEM Delta results	Coagulation function assessed by Quantra and ROTEM delta	Upon arrival to emergency department
Comparison of the Quantra Clot Stiffness results to ROTEM Delta results	Coagulation function assessed by Quantra and ROTEM delta	Upon arrival to emergency department
Comparison of the Quantra Fibrinolysis results to ROTEM Delta results	Coagulation function assessed by Quantra and ROTEM delta	Upon arrival to emergency department

Collaborators and Investigators

• Sponsor: HemoSonics LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Actual): January 29, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: April 20, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 2, 2019

Study Record Updates

• Last Update Posted (Actual): February 13, 2020
• Last Update Submitted That Met QC Criteria: February 11, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Hemostasis; Coagulation; Quantra; Viscoelastic testing
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: HEMCS-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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.: No