Quantra Determination of Coagulation Parameters in Arterial and Venous Blood

April 18, 2017 updated by: HemoSonics LLC

Comparison of Coagulation Parameters in Arterial and Venous Blood Measured Using the Quantra System

The Quantra™ System is a novel point-of-care diagnostic device designed to perform whole blood coagulation analysis. This study compares Quantra measurements determined in arterial versus venous blood samples obtained from patients undergoing cardiac surgery.

Study Overview

Status

Completed

Conditions

Cardiac Surgery

Detailed Description

The Quantra System is a fully integrated and automated in vitro diagnostic device which utilizes SEER Sonorheometry, an ultrasound-based technology, to characterize the dynamic changes in the viscoelastic properties of a blood sample during coagulation and clot lysis. Viscoelastic testing performed using existing technologies is typically performed on arterial samples obtained from patients undergoing surgical procedures, although reference ranges for these tests have been established for venous blood only.

The aim of this study is to evaluate potential differences between Quantra measurements determined in arterial versus venous blood samples obtained from patients undergoing cardiac surgery.

Study Type

Observational

Enrollment (Actual)

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, 22903
    - University of Virginia

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device.

Description

Inclusion Criteria:

Subject is scheduled for cardiac surgery, utilizing cardiopulmonary bypass, or including placement of a ventricular assist device
Subject is ≥18 years
Subject is willing to participate and he/she has signed a consent form
Subject may participate if they have a history of bleeding or are on preoperative anticoagulant therapy

Exclusion Criteria:

Subject is unable to provide written informed consent
Subject is younger than 18 years
Subject is incarcerated at the time of the study
Subject is currently enrolled in a study that may confound the results of the proposed study
Subject is affected by a condition that, in the opinion of the surgical team, may pose additional risks

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Clot Time and Clot Stiffness results between arterial and venous samples Time Frame: Up to 24 hours	Coagulation function assessed by Quantra at 2 time points (Baseline and either during cardiac bypass or post-bypass)	Up to 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Quantra results to standard coagulation test results in venous samples Time Frame: Up to 24 hours	Coagulation function assessed by Quantra and standard coagulation tests at 2 time points (Baseline and either during cardiac bypass or post-bypass)	Up to 24 hours
Comparison of Quantra results to comparable ROTEM results in venous samples Time Frame: Up to 24 hours	Coagulation function assessed by Quantra and ROTEM at 2 time points (Baseline and either during cardiac bypass or post-bypass)	Up to 24 hours

Collaborators and Investigators

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

Sponsor

HemoSonics LLC

Collaborators

University of Virginia

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 (Actual)

July 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

November 28, 2016

First Submitted That Met QC Criteria