NCT03931031

Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (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 QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.

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 QPlus 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 single-site, prospective, observational study will evaluate the performance of the Quantra System as compared to standard coagulation tests and comparable measures determined using TEG in patients taking antiplatelet medication that are scheduled to undergo cardiac surgery.

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: 2019-03-21
• Primary completion: 2020-04-07
• Completion: 2020-06-27
• First posted: 2019-04-29
• Last updated: 2020-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study