HemoSonics-UVA Spinal Surgery



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:5/12/2016
Start Date:April 2015
End Date:August 2015

Use our guide to learn which trials are right for you!

HemoSonics-UVA Spinal Surgery Clinical Study Protocol

This study compares the results of current standard coagulation measurement devices to the
Quantra System, a new device, using small amount of extra blood obtained during routine
blood draws in neurosurgery patients.

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)
We found this trial at
1
site
Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials