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

Completed

• Conditions: Coagulation
• Interventions: Diagnostic Test: Quantra System

• Registration Number: NCT03139097
• Lead Sponsor: HemoSonics LLC

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-01-16
• Study First Submitted: 2017-04-18
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-03
• Primary Completion: 2017-09-28
• Study Completion: 2017-09-28
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Quantra System	Blood samples from healthy volunteers analyzed on the Quantra System.

Primary Outcome Measures

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

Trial Locations

Locations (3)

Creedmoor Centre Endocrinology; 🇺🇸 Raleigh, North Carolina, United States

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States