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

Quantra QStat in Trauma and Liver Transplant

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. These patients include the trauma and liver transplant populations. 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 multi-center, prospective, observational pilot study will evaluate the performance of the Quantra System with the QStat Cartridge as compared to conventional viscoelastic testing methods in blood samples obtained from trauma patients and patients undergoing liver transplant.

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To learn more, visit ClinicalTrials.Gov or contact Clinical Research at 864-560-6812.

Principal Investigator(s)

Brian Thurston, MD

Sponsor(s)

HemoSonics, LLC

Key Trial Criteria

For a patient to be eligible for participation in this study, all of the following criteria must apply.
- Subject is > 18 years
- Subject is a trauma patient experiencing traumatic injuries requiring a full trauma team response OR Subject is a patient undergoing liver transplant surgery.
- Subject, or subject's legally authorized representative (LAR), is willing to provide informed consent, either prospectively or by deferred consent, OR Institutional Review Board (IRB)/Ethics Committee (EC) has waived the requirement to obtain informed consent.
A patient will not be eligible for participation in this study if any of the following criteria apply.
- Subject is younger than 18 years of age
- Subject is pregnant.
- Subject is incarcerated at the time of the study.
- Subject is currently enrolled in a distinct study that might confound the result of the proposed study
- Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks.

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