NCT03139097

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 158 (actual)
• Sponsor: HemoSonics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Coagulation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Quantra System	Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Timeline

• Start date: 2017-01-16
• Primary completion: 2017-09-28
• Completion: 2017-09-28
• First posted: 2017-05-03
• Last updated: 2018-04-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study