Trials / Completed
CompletedNCT04219371
Reference Range Study for the Quantra QStat System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 140 (actual)
- Sponsor
- HemoSonics LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The objective is to determine the reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.
Detailed description
This is a multicenter, prospective, observational study of a healthy adult population with normal coagulation function to determine the 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
- 2020-01-07
- Primary completion
- 2020-04-17
- Completion
- 2020-06-30
- First posted
- 2020-01-07
- Last updated
- 2020-07-28
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04219371. Inclusion in this directory is not an endorsement.