QStat Pilot Reference Range Study

Completed

Conditions studied: Coagulation Disorder

In brief

The objective is to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.

Key facts

Study ID

NCT04490759

Run by

HemoSonics LLC

People needed

40

Starts

2018-11-29

Expected to finish

2019-07-16

Last updated by the study team

2020-07-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: 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 restuls 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

• M3 Wake Research — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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