Reference Range Study for the Quantra Analyzer With the Quantra Surgical Cartridge

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

158 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-16

Study Completion Date

2017-09-28

Brief Summary

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This study will establish reference range intervals for the Quantra System, a next-generation diagnostic platform that provides whole blood coagulation testing at the point-of-care.

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Detailed Description

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The Quantra System is a fully integrated and automated in vitro diagnostic device which uses SEER Sonorheometry, an ultrasound-based technology, to characterize the viscoelastic properties of a whole blood sample during coagulation. The Quantra Surgical Cartridge was developed to monitor hemostasis during major surgical procedures in adult patients. The cartridge consists of four independent channels each containing different sets of reagents, which provide four measurements performed in parallel yielding six parameters that depict the functional status of a patient's coagulation system. In this multi-center, prospective, observational study, blood samples will be obtained from healthy adult volunteers to establish a normal reference range for the test parameters measured by the Quantra System.

Conditions

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Coagulation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Volunteers

Blood samples from healthy volunteers analyzed on the Quantra System.

Quantra System

Intervention Type DIAGNOSTIC_TEST

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Interventions

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Quantra System

Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Quantra Surgical Cartridge

Eligibility Criteria

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Inclusion Criteria

* Subject is \> 18 years
* Subject is willing to participate and he/she has signed a consent form
* Subject's laboratory coagulation test results at screening are within each test's normal reference range

Exclusion Criteria

* Subject is younger than 18 years
* Subject has a history of a coagulation disorder
* Subject is pregnant or lactating
* Subject is currently taking medications known to alter coagulation
* Subject had a blood transfusion or surgery within the last month
* Subject has one or more laboratory coagulation test result outside of the normal reference range at screening
* Drug abuse
* Excessive alcohol consumption
* Subject is unable to provide written informed consent
* Subject is incarcerated at the time of the study
* Subject previously participated in this study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes