HemoSonics-UVA Spinal Surgery

HemoSonics is developing a novel POC diagnostic device, the Quantra System, to perform whole blood coagulation analysis and which is suitable for use in surgical and intensive care settings. The Quantra System employs a patented technology named sonorheometry, which was invented at the University of Virginia.

Sonorheometry uses ultrasound pulses to characterize the dynamic changes in viscoelastic properties of a blood sample during coagulation and clot lysis. The initial assay performed on the Quantra System will be the surgical assay for monitoring hemostasis during major surgical procedures in adult patients.

A clinical study will be conducted to evaluate the analytical performance as well as compared to existing coagulation monitoring technology

Inclusion criteria

• • Subject is scheduled for major deformity correction spine surgery

• Subject is older than 18 years
• 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 incarcerated at the time of the study
• Subject is affected by any condition that, in the opinion of the surgical team, may pose additional risks
• Subjects with renal disease (defined as serum creatinine greater than 1.5 mg/dl)
• Subjects with history of active liver disease
• Subjects affected by Factor V Leiden mutation
• Subjects affected by von Willebrand disease
• Subjects with an history of thrombotic disease (more than one DVT)