Clinical trial NCT03934983: Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma
Official title: Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Loss Massive
Trauma
Keywords: Viscoelastic testing
Coagulation
Quantra
Hemostasis
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
First posted: 2019-05-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Comparison of the Quantra Clot Time results to standard coagulation test results
timeFrame: Upon arrival to emergency department
measure: Comparison of the Quantra Clot Stiffness results to standard coagulation test results
timeFrame: Upon arrival to emergency department
measure: Comparison of the Quantra Clot Time results to ROTEM Delta results
timeFrame: Upon arrival to emergency department
measure: Comparison of the Quantra Clot Stiffness results to ROTEM Delta results
timeFrame: Upon arrival to emergency department
measure: Comparison of the Quantra Fibrinolysis results to ROTEM Delta results
timeFrame: Upon arrival to emergency department
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
References: