QStat Pilot Reference Range Study

HemoSonics

Status: Completed

Conditions: Coagulation Disorder

Treatments: Diagnostic Test: Quantra System

Study type: Observational

Funder types: Industry

Identifiers

NCT04490759

HEMCS-020

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 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

Trial design

40 participants in 1 patient group

Healthy volunteers

Description:

Blood samples from healthy volunteers analyzed on the Quantra System

Treatment:

Diagnostic Test: Quantra System