Hemosonics- VCU Cardiac Surgery Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Cardiopulmonary Bypass
• Intervention / Treatment: Device: Coagulation function

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.

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants for this study will be recruited at the Virginia Commonwealth University Medical Center. The subject population will be representative of the local racial and ethnic population.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cardiac Surgery Patients; 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	Device: Coagulation function; Coagulation function assessment tools TEG (standard of practice) vs SEER Quantra (novel coagulation function device)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clot Time	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	1 day
Clot Stiffness	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	1 day

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: HemoSonics LLC
• Investigators: Principal Investigator: Bruce Speiss, M.D., Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: March 12, 2015
• First Submitted That Met QC Criteria: March 17, 2015
• First Posted (Estimate): March 18, 2015

Study Record Updates

• Last Update Posted (Estimate): July 12, 2016
• Last Update Submitted That Met QC Criteria: June 1, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: FTU-002-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO