Quantra Determination of Coagulation Parameters in Arterial and Venous Blood

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

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No