Reference Range Study for the Quantra QStat System

N/ACompletedNCT04219371

HemoSonics LLC140 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

140

Conditions

Coagulation Disorder

Interventions

Quantra SystemDIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

Reference range intervals for measurement of Clot Time (CT) parameter

Reference range intervals determined in this study will serve as the reference range for CT on the QStat Cartridge when it is commercially available.