HemoSonics-UVA HemoSonics-UVA Cardiac Surgery Clinical Study Protocol

October 26, 2016 updated by: Danja Groves, MD, University of Virginia

HemoSonics-UVA 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

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 University of Virginia Health System and will involve patients undergoing cardiac surgery requiring bypass.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (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 UVA. 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 with renal disease (defined as serum creatinine greater than 1.5 mg/dl)
  • Patients with history of active liver disease
  • Patients on emergency cases
  • Patients on heparin anticoagulation before the beginning of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cardiac Surgery Patients
Intervention: Procedure: Blood specimen collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clot time
Time Frame: 1 day
Coagulation Function
1 day
Clot Amplitude
Time Frame: 1 day
Coagulation Function
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

HemoSonics LLC

Investigators

  • Principal Investigator: Danja Groves, MD, UVA Anesthesiology Faculty

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17923:

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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