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

NCT ID: NCT03934983

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-28
• Study Completion Date: 2020-01-31

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.

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.

Conditions

Blood Loss Massive; Trauma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Trauma patients

Subject experiencing major trauma such that viscoelastic testing is performed as standard of care to assess coagulopathy.

Quantra System

Intervention Type: DIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Interventions

Quantra System

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Quantra QStat Cartridge

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HemoSonics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

Other Identifiers

HEMCS-021

Identifier Type: -

Identifier Source: org_study_id