Reference Range Study for the Quantra Analyzer With the Quantra Surgical Cartridge

Coagulation Clinical Trial

Official title:

Reference Range Study for the Quantra Analyzer With the Quantra Surgical Cartridge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139097
• Other study ID #: HEMCS-010
• Status: Completed
• First received: April 18, 2017
• Last updated: April 4, 2018
• Start date: January 16, 2017
• Est. completion date: September 28, 2017

Study information

• Verified date: April 2018
• Source: HemoSonics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will establish reference range intervals for the Quantra System, a next-generation diagnostic platform that provides whole blood coagulation testing at the point-of-care.

Description:

The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra Surgical Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system. In this multi-center, prospective, observational study, blood samples will be obtained from healthy adult volunteers to establish a normal reference range for the test parameters measured by the Quantra System.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: September 28, 2017
• Est. primary completion date: September 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject is > 18 years

• Subject is willing to participate and he/she 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 had a blood transfusion or surgery within the last month

• Subject has one or more laboratory coagulation test result outside of the normal reference range at screening

• 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

• Coagulation

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	University of Maryland Medical Center	Baltimore	Maryland
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Creedmoor Centre Endocrinology	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, Heparinase Clot Time, Clot Stiffness, Fibrinogen Contribution and Platelet Contribution on the Quantra System	Reference range intervals determined in this study from the analysis of blood samples collected from healthy adults will serve as the initial reference ranges for the Quantra test parameters when the Surgical Cartridge is commercially available.	Baseline, determined from single blood draw