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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03934983
Other study ID # HEMCS-021
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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