QStat Pilot Reference Range Study

Reference Range Pilot Study for the Quantra Analyzer With the QStat Cartridge

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

Study Overview

• Status: Completed
• Conditions: Coagulation Disorder
• Intervention / Treatment: Diagnostic test: Quantra System

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult volunteers with normal coagulation function, approximately equal numbers of males and females across three age group categories (18-30, 31-50 and >50 years). The racial and ethnic profiles will be representative of the populations at the site.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy volunteers; Blood samples from healthy volunteers analyzed on the Quantra System	Diagnostic test: Quantra System; Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.; Other Names: QStat Cartridge

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HemoSonics LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 29, 2018
• Primary Completion (ACTUAL): December 4, 2018
• Study Completion (ACTUAL): July 16, 2019

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (ACTUAL): July 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders
• Other Study ID Numbers: HEMCS-020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes