QStat Pilot Reference Range Study

NCT ID: NCT04490759

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-29

Study Completion Date

2019-07-16

Brief Summary

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

Detailed Description

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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.

Conditions

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Coagulation Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy volunteers

Blood samples from healthy volunteers analyzed on the Quantra System

Quantra System

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Quantra System

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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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QStat Cartridge

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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HemoSonics LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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M3 Wake Research

Raleigh, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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HEMCS-020

Identifier Type: -

Identifier Source: org_study_id

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