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Completed

NCT Number: NCT02392247

Hemosonics- VCU Cardiac Surgery Clinical Study

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.

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Key information

Conditions

Cardiopulmonary Bypass

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coagulation function

Device

Coagulation function assessment tools TEG (standard of practice) vs SEER Quantra (novel coagulation function device)

Primary outcomes

  1. Clot Time

    Time frame: 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

  2. Clot Stiffness

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • HemoSonics LLC

Registry information

Official study title

Hemosonics- VCU Cardiac Surgery Clinical Study Protocol

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2015
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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