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Completed

NCT Number: NCT04490759

QStat Pilot Reference Range Study

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

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Key information

Conditions

Coagulation Disorder Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

M3 Wake Research

Raleigh, North Carolina, 27612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quantra System

Diagnostic Test

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

Other names: QStat Cartridge

Primary outcomes

  1. Reference range intervals for measurement of Clot Time (CT) parameter

    Time frame: 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.

  2. Reference range intervals for measurement of Clot Stiffness (CS) parameter

    Time frame: 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.

  3. Reference range intervals for measurement of Fibrinogen Contribution to Clot Stiffness (FCS) parameter

    Time frame: 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.

  4. Reference range intervals for measurement of Platelet Contribution to Clot Stiffness (PCS) parameter

    Time frame: 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.

  5. Reference range intervals for measurement of Clot Stability to Lysis (CSL) parameter

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

HemoSonics LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jul 29, 2020
Registry last updated
Jul 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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