NCT03685097

Comparison of Two Point-of-care Devices for Viscoelastic Hemostasis Assays

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: HemoSonics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests in cardiac surgery patients. In addition the association of Quantra-derived parameters with select platelet function tests will be investigated.

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 (previously called the Surgical Cartridge), was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge provides six parameters that depict the functional status of a patient's coagulation system. This single site, prospective observational study will investigate the correlation and agreement of Quantra-derived parameters with parameters reported by the ROTEM delta and standard laboratory tests (PT, aPTT, fibrinogen, platelet count) in cardiac surgery patients. As an additional exploratory study, the association of Quantra-derived parameters with select platelet function tests will be investigated.

Conditions

• Coagulation Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Quantra System with the QPlus Cartridge	Point-of-care viscoelastic testing

Timeline

• Start date: 2018-03-01
• Primary completion: 2018-07-31
• Completion: 2018-08-31
• First posted: 2018-09-26
• Last updated: 2018-09-26

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated device study