Reference Range Study for the Quantra Analyzer With the Quantra Surgical Cartridge
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- HemoSonics LLC
- Enrollment
- 158
- Locations
- 3
- Primary Endpoint
- Reference range intervals for measurement of Clot Time, Heparinase Clot Time, Clot Stiffness, Fibrinogen Contribution and Platelet Contribution on the Quantra System
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Reference range intervals for measurement of Clot Time, Heparinase Clot Time, Clot Stiffness, Fibrinogen Contribution and Platelet Contribution on the Quantra System
Time Frame: Baseline, determined from single blood draw
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.
Secondary Outcomes
No secondary outcomes reported