Hemosonics- VCU Cardiac Surgery Clinical Study

Completed

• Conditions: Cardiopulmonary Bypass
• Interventions: Device: Coagulation function

• Registration Number: NCT02392247
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-18
• Study Start: 2015-04
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2016-02-25
• Status Verified: 2016-06
• Results First Submitted QC: 2016-06-01
• Last Update Submitted: 2016-06-01
• Results First Posted: 2016-07-12
• Last Update Posted: 2016-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cardiac Surgery Patients	Coagulation function	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

Primary Outcome Measures

Name	Time	Method
Clot Time	1 day	Coagulation Function assessed at 4 time points \[baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU\] over the course of cardiac surgery until patient ICU transfer
Clot Stiffness	1 day	Coagulation Function assessed at 4 time points (baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU) over the course of cardiac surgery and bypass until patient ICU transfer

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States