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

NCT03139097 | Completed FDA Device

• 1 other identifier: HEMCS-010
• Study Type: observational
• Target: 158
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Coagulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Healthy Volunteers

Blood samples from healthy volunteers analyzed on the Quantra System.

Diagnostic Test: Quantra System

Interventions

Quantra System DIAGNOSTIC_TEST

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

Also known as: Quantra Surgical Cartridge

Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult volunteers with normal coagulation function, approximately equal numbers of males and females across three age group categories (18-30, 31-50 and \>50 years). The racial and ethnic profiles will be representative of the populations at each site.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• HemoSonics LLC: lead

Study Sites (3)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Creedmoor Centre Endocrinology

Raleigh, North Carolina, 27615, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Thrombosis

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Julia Warren-Ulanch, MD

  Creedmoor Centre Endocrinology

  PRINCIPAL INVESTIGATOR

• Charles Greenberg, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Kenichi Tanaka, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: May 3, 2017
• Study Start: January 16, 2017
• Primary Completion: September 28, 2017
• Study Completion: September 28, 2017
• Last Updated: April 5, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)