Status:
COMPLETED
QStat Pilot Reference Range Study
Lead Sponsor:
HemoSonics LLC
Conditions:
Coagulation Disorder
Eligibility:
All Genders
18+ years
Brief Summary
The objective is to determine the initial reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge.
Detailed Description
This is a single center prospective, observational study of a healthy adult population with normal coagulation function to determine the initial reference range intervals for the parameters reported b...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
November 29 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 16 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04490759
Start Date
November 29 2018
End Date
July 16 2019
Last Update
July 29 2020
Active Locations (1)
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1
M3 Wake Research
Raleigh, North Carolina, United States, 27612