NCT04219371

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 7, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

January 7, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

January 2, 2020

Last Update Submit

July 24, 2020

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 SystemDIAGNOSTIC_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

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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 each 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, 30328, United States

Location

M3 Wake Research

Raleigh, North Carolina, 27612, United States

Location

WR-ClinSearch, LLC

Chattanooga, Tennessee, 37421, United States

Location

MeSH Terms

Conditions

Hemostatic Disorders

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHemorrhagic DisordersHematologic DiseasesHemic 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

January 2, 2020

First Posted

January 7, 2020

Study Start

January 7, 2020

Primary Completion

April 17, 2020

Study Completion

June 30, 2020

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

US(3)