QStat Pilot Reference Range Study

NCT04490759 | Completed FDA Device

• 1 other identifier: HEMCS-020
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coagulation Disorder

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Healthy volunteers

Blood samples from healthy volunteers analyzed on the Quantra System

Diagnostic Test: Quantra System

Interventions

Quantra System DIAGNOSTIC_TEST

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

Also known as: QStat Cartridge

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• HemoSonics LLC: lead

Study Sites (1)

M3 Wake Research

Raleigh, North Carolina, 27612, United States

Location

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: July 29, 2020
• Study Start: November 29, 2018
• Primary Completion: December 4, 2018
• Study Completion: July 16, 2019
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)