Clinical trial NCT04219371: Reference Range Study for the Quantra QStat System
Official title: Reference Range Study for the Quantra QStat System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation Disorder
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
First posted: 2020-01-07
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult volunteers with normal coagulation function, approximately equal numbers of males and females across three age group categories (18-30, 31-50 and \>50 years). The racial and ethnic profiles will be representative of the populations at each site.

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

Detailed description: This is a multicenter, prospective, observational study of a healthy adult population with normal coagulation function to determine the reference range intervals for the parameters reported by the Quantra System with the QStat Cartridge. The threshold for the Clot Stability to Lysis (CSL) parameter will be determined from the CSL reference range.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Reference range intervals for measurement of Clot Time (CT) parameter
timeFrame: Baseline, determined from a single blood draw
measure: Reference range intervals for measurement of Clot Stiffness (CS) parameter
timeFrame: Baseline, determined from a single blood draw
measure: Reference range intervals for measurement of Fibrinogen Contribution to Clot Stiffness (FCS) parameter
timeFrame: Baseline, determined from a single blood draw
measure: Reference range intervals for measurement of Platelet Contribution to Clot Stiffness (PCS) parameter
timeFrame: Baseline, determined from a single blood draw
measure: Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter
timeFrame: Baseline, determined from a single blood draw
Secondary outcomes:
Other outcomes:
Locations:
city: Sandy Springs
country: United States
facility: WR-Mount Vernon Clinical Research, LLC
state: Georgia
city: Raleigh
country: United States
facility: M3 Wake Research
state: North Carolina
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC
state: Tennessee
Study officials:
References: