Reference Range Study for the Quantra QStat System

Completed

• Conditions: Coagulation Disorder

• Registration Number: NCT04219371
• Lead Sponsor: HemoSonics LLC

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2020-01-02
• Study First Submitted QC: 2020-01-03
• Study Start: 2020-01-07
• Study First Posted: 2020-01-07
• Primary Completion: 2020-04-17
• Study Completion: 2020-06-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reference range intervals for measurement of Clot Time (CT) parameter	Baseline, determined from a single blood draw	Reference range intervals determined in this study will serve as the reference range for CT on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Clot Stiffness (CS) parameter	Baseline, determined from a single blood draw	Reference range intervals determined in this study will serve as the reference range for CS on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Fibrinogen Contribution to Clot Stiffness (FCS) parameter	Baseline, determined from a single blood draw	Reference range intervals determined in this study will serve as the reference range for FCS on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Platelet Contribution to Clot Stiffness (PCS) parameter	Baseline, determined from a single blood draw	Reference range intervals determined in this study will serve as the reference range for PCS on the QStat Cartridge when it is commercially available.
Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter	Baseline, determined from a single blood draw	Reference range intervals determined in this study will serve as the reference range for CSL on the QStat Cartridge when it is commercially available.

Trial Locations

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