Deformity of Spine Clinical Trial
Official title:
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
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Observational Model: Cohort, Time Perspective: Prospective
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