NCT03152461

Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge

Evaluation of the Clinical Performance of the Quantra System With the Quantra Surgical Cartridge in Adult Patients Undergoing Major Surgical Procedures

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 302 (actual)
• Sponsor: HemoSonics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the Quantra Surgical Cartridge in patients undergoing major surgical procedures specifically, major cardiac and vascular procedures and major orthopedic surgery (primarily complex spine surgeries).

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. This multi-center, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using the ROTEM Delta.

Conditions

• Blood Loss, Surgical

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: 2017-05-23
• Primary completion: 2018-02-09
• Completion: 2018-02-09
• First posted: 2017-05-15
• Last updated: 2018-07-31

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study