Richmond, Virginia 23298


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.

Study summary:

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.


Inclusion Criteria: - Subject is scheduled for cardiac surgery involving bypass circuit - 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 - Patients on emergency cases



Primary Contact:

Emily Cochran, RN
Phone: 804-628-4902

Backup Contact:


Location Contact:

Richmond, Virginia 23298
United States

Emily Cochran
Phone: 804-628-4902

Site Status: Recruiting

Data Source:

Date Processed: June 25, 2018

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