Hemosonics- VCU Cardiac Surgery Clinical Study

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Cardiopulmonary Bypass

Treatments: Device: Coagulation function

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02392247

FTU-002-007

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

52 participants in 1 patient group

Cardiac Surgery Patients

Description:

Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry

Treatment:

Device: Coagulation function