Adult MDW Dual Cut-Off Accuracy Study (MDW)

March 13, 2025 updated by: Beckman Coulter, Inc.

UniCel DxH 900/690T Monocyte Distribution Width (MDW) Dual Cut-Off Clinical Accuracy Protocol

This study will establish the clinical performance of the Monocyte Distribution Width (MDW) parameter on the DxH 900/ DxH 690T hematology analyzers to aid in the detection and risk assessment of patients in the Emergency Department (ED) for progression to sepsis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to validate the MDW dual cut-off values established during characterization and demonstrate the performance of MDW to detect sepsis in a multi-center study of adults presenting to the ED who have CBC w/diff ordered within 12 hours of presentation.

This study is designed to enroll all-comers from selected sites that currently have a DxH 900 in use as part of routine testing in the ED. All subjects who meet the Inclusion Criteria will be included in the study, without enrichment. Data from all subjects meeting the Inclusion Criteria will be provided to a panel of independent adjudicators. Adjudicators will be blinded to the MDW result and any sepsis diagnostic determinations which may or may not be in the original medical record.

Study Type

Observational

Enrollment (Estimated)

2225

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All-comers study of adult patients (18 to 89 years) of all races and ethnicities presenting to the ED

Description

Inclusion Criteria:

  • Adults (18 to 89 years) of all races and ethnicities presenting to the ED
  • Whole Blood venous samples collected in K2EDTA while the patient was in the ED
  • First CBC w/diff test ordered within 12 hours of presentation to ED as part of their standard medical care
  • CBC w/diff tested within 2 hours of specimen collection
  • Subjects with at least ≥12 hours of follow-up in the ED (or inpatient, if admitted) from presentation

Exclusion Criteria:

  • CBC w/diff test ordered after 12 hours of presentation to ED
  • Subjects previously enrolled in this study (i.e. subjects may not be enrolled more than once in this study)
  • Subjects discharged from ED <12 hours from ED presentation
  • ED Transfer Patients

Data Exclusions Post Enrollment:

  • Samples that have a system generated flag from the Standard of Care (SOC) CBC w/diff testing will be excluded.
  • Samples with instrument flags, including vote outs and review flags for MDW will also be excluded (i.e. invalid MDW results).
  • Subjects' data collected with Instrument Quality Control failure(s).

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adults presenting to Emergency Department
All-comers study of adults (18 to 89 years) of all races and ethnicities presenting to the Emergency Department
Diagnostic test: Complete Blood Count with differential
First CBC w/diff test ordered within 12 hours of presentation to ED as part of standard medical care. The MDW result will be used as diagnostic marker to predict the risk of developing sepsis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance of MDW
Time Frame: through study completion, an average of 1 year
Clinical performance of MDW (expressed in terms of its interpretation bands and likelihood ratios) in diagnosing sepsis determined by clinical adjudication.
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Beckman Coulter, Inc.

Collaborators

University of Kansas Medical Center
Hackensack Meridian Health
Indiana University Health

Investigators

  • Study Director: Alicia Drain, BSc, Beckman Coulter, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

May 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 13, 2025

First Submitted That Met QC Criteria

March 13, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D25391

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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