Trials / Completed
CompletedNCT05290675
Quantra QPlus Sample Type Comparison
Impact of Sample Type and Assay Time on the Performance of the Quantra QPlus System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (actual)
- Sponsor
- HemoSonics LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a single center prospective observational study to compare QPlus parameter measurements in arterial and venous blood samples collected in parallel from patients undergoing cardiac surgery.
Detailed description
In this single center prospective observational study, 40 cardiac surgery subjects will enrolled, each with parallel artrial and venous samples collected at 3 time points to yield 120 matched samples for analysis on the Quantra System with the QPlus Cartridge.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Quantra QPlus System | Whole blood coagulation testing system |
Timeline
- Start date
- 2021-11-04
- Primary completion
- 2022-08-31
- Completion
- 2022-11-02
- First posted
- 2022-03-22
- Last updated
- 2023-05-01
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05290675. Inclusion in this directory is not an endorsement.