Trials / Completed
CompletedNCT04490759
QStat Pilot Reference Range Study
Reference Range Pilot Study for the Quantra Analyzer With the QStat Cartridge
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 40 (actual)
- Sponsor
- HemoSonics LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective is to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.
Detailed description
This is a single center prospective, observational study of a healthy adult population with normal coagulation function to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge. The threshold for the Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.
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
- 2018-11-29
- Primary completion
- 2018-12-04
- Completion
- 2019-07-16
- First posted
- 2020-07-29
- Last updated
- 2020-07-29
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04490759. Inclusion in this directory is not an endorsement.