Blood Loss, Surgical
Conditions
Keywords
Viscoelastic testing, Coagulation, Quantra, Hemostasis
Brief summary
This study will assess the clinical performance of the Quantra System with the QStat Cartridge in the liver transplant population.
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 propoerties of a whole blood sample during coagulation. The Quantra QStat Cartridge was developed to monitor hemostasis in the trauma and liver transplant populations which may experience a range of coagulopathies of various etiologies including fibrinolytic defects. This single-center, prospective, observational stuey will evaluate the performance of the Quantra System with the QStat Cartridge as compared to corresponding measures determined using the TEG 5000.
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
Healthy volunteers
No
Inclusion criteria
* Subject is ≥ 18 years of age * Subject is undergoing deceased donor liver transplant and is a candidate for a TEG test to be performed to access coagulopathy during surgery. * 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 is known to have received antifibrinolytic therapy immediately prior to the start of liver transplantation surgery. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of Quantra Clot Time results to TEG R results | Baseline, after induction of anesthesia, before surgical incision | Coagulation function assessed by Quantra and TEG 5000 |
| Comparison of Quantra Clot Stiffness results to TEG MA results | Baseline, after induction of anesthesia, before surgical incision | Coagulation function assessed by Quantra and TEG 5000 |
| Comparison of Quantra Clot Lysis results to TEG LI30 results | Baseline, after induction of anesthesia, before surgical incision | Coagulation function assessed by Quantra and TEG 5000 |
Countries
United States
Outcome results
None listed