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

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

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.

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.

Inclusion Criteria:

• Subject is >18 years
• Subject is undergoing elective cardiac surgery with cardiopulmonary bypass
• Subject is willing to participate and has signed a consent form

Exclusion Criteria:

• Subject is younger than 18 years
• Subject has known congenital coagulopathy
• Subject is unable to provide written informed consent