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

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.

Inclusion Criteria:

- Subject is ≥18 years

- Subject is scheduled for either 1) cardiac or vascular surgery utilizing
cardiopulmonary bypass (CPB) or 2) orthopedic surgery including major deformity
correction spine surgery

- Subject has a cardiac assist device and is hospitalized for any procedure

- Subject underwent cardiac, vascular or orthopedic surgery and presents with acute
bleeding or suspected hypercoagulability in a post-surgical unit

- Subject is undergoing emergency cardiac, vascular or orthopedic surgery

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

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 pregnant

- Subject is currently enrolled in a study that might confound the result of the
proposed study

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