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

Completed

Conditions studied: Blood Loss Massive, Trauma

In brief

This pilot study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QStat Cartridge in trauma patients.

Key facts

Study ID

NCT03934983

Run by

HemoSonics LLC

People needed

30

Starts

2019-03-28

Expected to finish

2020-01-31

Last updated by the study team

2020-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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