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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03145428
Other study ID # C03747
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 19, 2017
Est. completion date January 26, 2018

Study information

Verified date November 2019
Source Beckman Coulter, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The measurement of monocyte volume width distribution (MDW) is intended for use with adult patients presenting to the emergency department (ED), where a CBC with Differential has been ordered, as an aid in the early detection of patients with or developing sepsis. The study will establish the clinical performance of MDW for detection of sepsis in the ED.


Description:

A prospective multi-center study to establish the clinical utility of the measurement of monocyte volume width distribution, a cell population parameter of the CBC-Differential, on the Beckman Coulter Unicel DxH analyzers. The study will validate the cut-off for the early detection of sepsis in an adult emergency room population where the standard of care included a CBC with Differential and will evaluate the diagnostic performance of the parameter.


Recruitment information / eligibility

Status Completed
Enrollment 3000
Est. completion date January 26, 2018
Est. primary completion date December 22, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 89 Years
Eligibility Inclusion Criteria:

- Adults (18-89 years) presenting to ED

- All races & ethnicities

- CBC with Differential performed upon presentation

- Subjects with at least 12 hours of follow-up in ED (or in-patient if admitted)

Exclusion Criteria:

- Previously enrolled

- Subjects discharged <12 hours form ED presentation

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
CBC-Diff Monocyte volume width distribution (MDW)
MDW measurement used to detect sepsis. Results will not be used to manage patients

Locations

Country Name City State
United States The Ohio State University Columbus Ohio
United States Hackensack University Medical Center Hackensack New Jersey
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Beckman Coulter, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Identification of sepsis vs. non-sepsis, including SIRS and infection (non-SIRS) by adjudication based on the 2001 SCCM sepsis definition (sepsis-2) Determination of the diagnostic accuracy, area under the receiver operating characteristic curve 12 hours after presentation to the ED
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