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

Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934983
• Other study ID #: HEMCS-021
• Status: Completed
• Start date: March 28, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2020
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 31, 2020
• Est. primary completion date: January 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Loss Massive
• Trauma
• Wounds and Injuries

Intervention

Diagnostic Test:
• Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
HemoSonics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Comparison of the Quantra Clot Time results to ROTEM Delta results	Coagulation function assessed by Quantra and ROTEM delta	Upon arrival to emergency department
Primary	Comparison of the Quantra Clot Stiffness results to ROTEM Delta results	Coagulation function assessed by Quantra and ROTEM delta	Upon arrival to emergency department
Primary	Comparison of the Quantra Fibrinolysis results to ROTEM Delta results	Coagulation function assessed by Quantra and ROTEM delta	Upon arrival to emergency department