Cardiac Surgery Clinical Trial
Official title:
Hemosonics- VCU Cardiac 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 cardiac surgery 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 provide
a preliminary evaluation of the performance comparability of the HemoSonics' device as
compared to existing coagulation monitoring technology in heart surgery. This study will be
performed at HemoSonics and the Virginia Commonwealth University Medical Center and will
involve patients undergoing cardiac surgery requiring bypass.
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