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

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.

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Key information

Conditions

Coagulation Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Maryland Medical Center, Baltimore, Maryland, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quantra System

Diagnostic Test

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

Other names: Quantra Surgical Cartridge

Primary outcomes

Reference range intervals for measurement of Clot Time, Heparinase Clot Time, Clot Stiffness, Fibrinogen Contribution and Platelet Contribution on the Quantra System

Time frame: Baseline, determined from single blood draw

Reference range intervals determined in this study from the analysis of blood samples collected from healthy adults will serve as the initial reference ranges for the Quantra test parameters when the Surgical Cartridge is commercially available.

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: May 3, 2017
Registry last updated: Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed