Clinical trial NCT03139097: Reference Range Study for the Quantra Analyzer With the Quantra Surgical Cartridge
Official title: Reference Range Study for the Quantra Analyzer With the Quantra Surgical Cartridge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coagulation
Lead sponsor: HemoSonics LLC
Sponsor class: INDUSTRY
First posted: 2017-05-03
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Reference range intervals for measurement of Clot Time, Heparinase Clot Time, Clot Stiffness, Fibrinogen Contribution and Platelet Contribution on the Quantra System
timeFrame: Baseline, determined from single blood draw
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Raleigh
country: United States
facility: Creedmoor Centre Endocrinology
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Creedmoor Centre Endocrinology
name: Julia Warren-Ulanch, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Charles Greenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Kenichi Tanaka, MD
role: PRINCIPAL_INVESTIGATOR
References: