Reference Range Study for the Quantra QStat System
Completed
Conditions studied: Coagulation Disorder
In brief
The objective is to determine the reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.
Key facts
- Study ID
- NCT04219371
- Run by
- HemoSonics LLC
- People needed
- 140
- Starts
- 2020-01-07
- Expected to finish
- 2020-06-30
- Last updated by the study team
- 2020-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is 18 years or older
- Subject is willing to participate and has signed a consent form
- Subject's laboratory coagulation test results at screening are within each test's normal reference range.
You may not qualify if…
- Subject is younger than 18 years
- Subject has a history of a coagulation disorder
- Subject is pregnant or lactating
- Subject is currently taking medications known to alter coagulation
- Subject has one or more laboratory coagulation test results outside of the normal reference range at screening
- Subject had a blood transfusion or surgery within the last month
- Drug abuse
- Excessive alcohol consumption
- Subject is unable to provide written informed consent
- Subject is incarcerated at the time of the study
- Subject previously participated in this study
Where it is running
- WR-Mount Vernon Clinical Research, LLC — Sandy Springs, Georgia, United States
- M3 Wake Research — Raleigh, North Carolina, United States
- WR-ClinSearch, LLC — Chattanooga, Tennessee, United States
Full record on ClinicalTrials.gov
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