Reference Range Study for the Quantra Analyzer With the Quantra Surgical Cartridge

Completed

Conditions studied: Coagulation

In brief

This study will establish reference range intervals for the Quantra System, a next-generation diagnostic platform that provides whole blood coagulation testing at the point-of-care.

Key facts

Study ID

NCT03139097

Run by

HemoSonics LLC

People needed

158

Starts

2017-01-16

Expected to finish

2017-09-28

Last updated by the study team

2018-04-05

Who can join

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

You may qualify if…

• Subject is > 18 years
• Subject is willing to participate and he/she 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 had a blood transfusion or surgery within the last month
• Subject has one or more laboratory coagulation test result outside of the normal reference range at screening
• 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

• University of Maryland Medical Center — Baltimore, Maryland, United States
• Creedmoor Centre Endocrinology — Raleigh, North Carolina, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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