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Adult MDW Dual Cut-Off Accuracy Study

NCT06885528 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2225

Last updated 2025-03-20

No results posted yet for this study

Summary

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Indiana University Health

    collaborator OTHER

  • University of Kansas Medical Center

    collaborator OTHER

  • Hackensack Meridian Health

    collaborator OTHER

  • Beckman Coulter, Inc.

    lead INDUSTRY

Principal Investigators

  • Alicia Drain, BSc · Beckman Coulter, Inc.

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-03-31
Completion
2026-06-30
FDA Device
Yes

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06885528 on ClinicalTrials.gov