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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04490759
Other study ID # HEMCS-020
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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