QStat Pilot Reference Range Study

Coagulation Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490759
• Other study ID #: HEMCS-020
• Status: Completed
• Start date: November 29, 2018
• Est. completion date: July 16, 2019

Study information

• Verified date: July 2020
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 16, 2019
• Est. primary completion date: December 4, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Coagulation Disorder
• Hemostatic Disorders

Intervention

Diagnostic Test:
• Quantra System
Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Locations

Country	Name	City	State
United States	M3 Wake Research	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
HemoSonics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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