Quantra QStat in Trauma and Liver Transplant

HemoSonics LLC397 enrolled

Overview

This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing 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.

Study Type

OBSERVATIONAL

Enrollment

397

Conditions

Hemorrhage Trauma Liver Transplant

Interventions

Quantra SystemDIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (10)

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, United States

University of Colorado

Denver, Colorado, United States

University of Florida Health Shands Hospital

Gainesville, Florida, United States