Blood Loss, Surgical Clinical Trial
Official title:
Comparison of Methods and Coagulation Analysis Between ROTEM Sigma and Quantra System in Cardiac Surgery
This study compares the results of the Quantra System with the QPlus Cartridge to results obtained with the ROTEM sigma in patients undergoing cardia surgery utilizing cardiopulmonary bypass.
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 QPlus 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 coagulations system.
This single-center, prospective, observational study will evaluate the performance of the
Quantra System with the QPlus Cartridge as compared to comparable measures determined using
the ROTEM sigma.
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