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

HemoSonics

Status: Completed

Conditions: Coagulation

Treatments: Diagnostic Test: Quantra System

Study type: Observational

Funder types: Industry

Identifiers

NCT03139097

HEMCS-010

Details and patient eligibility

About

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.

Full description

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra Surgical Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system. In this multi-center, prospective, observational study, blood samples will be obtained from healthy adult volunteers to establish a normal reference range for the test parameters measured by the Quantra System.

Enrollment: 158 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

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 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

Trial design

158 participants in 1 patient group

Healthy Volunteers

Description:

Blood samples from healthy volunteers analyzed on the Quantra System.

Treatment:

Diagnostic Test: Quantra System