Trials / Completed
CompletedNCT04114253
QStat in Liver Transplant
Evaluation of the Clinical Performance of the Quantra System With the QStat Cartridge in Liver Transplant
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (actual)
- Sponsor
- HemoSonics LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Quantra System | Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care. |
Timeline
- Start date
- 2019-09-04
- Primary completion
- 2020-08-12
- Completion
- 2020-12-12
- First posted
- 2019-10-03
- Last updated
- 2021-01-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04114253. Inclusion in this directory is not an endorsement.