Quantra Determination of Coagulation Parameters in Arterial and Venous Blood

The Quantra System is a fully integrated and automated in vitro diagnostic device which
utilizes SEER Sonorheometry, an ultrasound-based technology, to characterize the dynamic
changes in the viscoelastic properties of a blood sample during coagulation and clot lysis.
Viscoelastic testing performed using existing technologies is typically performed on
arterial samples obtained from patients undergoing surgical procedures, although reference
ranges for these tests have been established for venous blood only.

The aim of this study is to evaluate potential differences between Quantra measurements
determined in arterial versus venous blood samples obtained from patients undergoing cardiac
surgery.

Inclusion Criteria:

- Subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or
including placement of a ventricular assist device

- Subject is ≥18 years

- Subject is willing to participate and he/she has signed a consent form

- Subject may participate if they have a history of bleeding or are on preoperative
anticoagulant therapy

Exclusion Criteria:

- Subject is unable to provide written informed consent

- Subject is younger than 18 years

- Subject is incarcerated at the time of the study

- Subject is currently enrolled in a study that may confound the results of the
proposed study

- Subject is affected by a condition that, in the opinion of the surgical team, may
pose additional risks