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HemoSonics-UVA HemoSonics-UVA Cardiac Surgery Clinical Study Protocol

NCT ID: NCT02456467

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-08-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac Surgery Patients

Intervention: Procedure: Blood specimen collection

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HemoSonics LLC

INDUSTRY

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Danja Groves, MD

Associate Professor, Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Danja Groves, MD

Role: PRINCIPAL_INVESTIGATOR

UVA Anesthesiology Faculty

Locations

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University of Virginia Health System

Charlottesville, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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17923:

Identifier Type: -

Identifier Source: org_study_id