Hemorrhage, Liver Transplant, Trauma
Conditions
Keywords
Viscoelastic testing, Coagulation, Trauma, Liver Transplant, Quantra, QStat
Brief summary
This is a multi-center prospective, observational study of the Quantra System with the QStat Cartridge in trauma patients and patients undergoing liver transplant.
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. 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.
Interventions
DIAGNOSTIC_TESTQuantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
Sponsors
HemoSonics LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Quantra Clot Time (CT) to ROTEM Delta INTEM CT results | Upon arrival of trauma subject to the emergency department | Coagulation function assessed by Quantra and ROTEM Delta |
| Comparison of Quantra Clot Stiffness (CS) to ROTEM Delta EXTEM A20 results | Upon arrival of trauma subject to the emergency department | Coagulation function assessed by Quantra and ROTEM Delta |
| Comparison of Quantra Fibrinogen Contribution (FCS) to ROTEM Delta FIBTEM A20 results | Upon arrival of trauma subject to the emergency department | Coagulation function assessed by Quantra and ROTEM Delta |
| Comparison of Quantra Clot Stability to Lysis (CSL) to ROTEM Delta EXTEM ML results | Upon arrival of trauma subject to the emergency department | Coagulation function assessed by Quantra and ROTEM Delta |
Countries
United States
Outcome results
None listed